Syneos Health

The Clinical Research Associate II / Sr CRA is responsible for site qualification, initiation, monitoring, and close-out visits, ensuring compliance with regulatory and protocol standards. They will assess site performance, manage communication with site personnel, and support patient recruitment and retention strategies. | Candidates must have a Bachelor’s degree or RN in a related field and knowledge of Good Clinical Practice/ICH Guidelines. Strong computer skills, excellent communication abilities, and the capacity to manage travel of up to 75% are also required. | Clinical Research Associate II / Sr CRA - Full Service - (Home-Based in Central US) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Ability to manage required travel of up to 75% on a regular basis US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

The Sr Regulatory Associate PM performs detailed project-related duties related to regulatory submissions and compliance. Responsibilities include preparing and submitting applications, conducting quality control reviews, and maintaining regulatory databases. | Candidates should have 3-5 years of regulatory experience and a BS/BA degree or equivalent practical experience. Strong analytical skills and the ability to work independently are essential. | Sr Regulatory Associate PM (US or LATAM Based Only) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities **Fully Remote in US and LATAM Only. Must be eligible to work in US or LATAM without Visa sponsorship in order to be considered. -Under limited supervision, performs detailed and confidential project-related duties directly related to regulatory submissions and regulatory compliance. -May also perform limited general project administrative duties. -Responsibilities typically include creating and editing regulatory reports, summarization of data in the public domain, conduct quality control review of documents, and may also include collection and analysis of data to produce reports to support investigational new drug applications(INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorization transfers (MATs) and other lifecycle maintenance activities. JOB RESPONSIBILITIES Essential Functions: For non-complex submissions, independently fulfill the following responsibilities. For complex submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues: -Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations. -Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures. -Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts. - Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements. -Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client. -Attends client meetings as needed and builds client relationship in support of projects and deliverables. -Systematically reviews Regulatory Associates or other Senior Associate’s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project. -Identifies risks to project delivery related to own workload and appropriate escalation. For identified non-complex issues, provide proposals for issue resolution. - Assists in training and mentoring of team members depending upon project requirements. Create and Maintain Content Plans within Veeva Vault RIM Translating Smartsheet timelines into Microsoft Project and Veeva Vault RIM Assist with planning, managing, and tracking of regulatory submissions Qualifications - External QUALIFICATION REQUIREMENTS: 3-5 years of Regulatory Experience within Industry BS/BA degree or equivalent practical experience. Experience in a work-related area preferred. Excellent interpersonal / communication skills. Advanced skills in Microsoft Office Applications. Strong analytical skills. Ability to work independently and to understand and carry out detailed instructions. Ability to interact with staff from multiple departments. Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Fluent in speaking, writing, and reading English. In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards. Keywords: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. The annual base salary for this position ranges from $47,000-$79,900 USD. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Best, At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Lead and oversee global Phase I clinical trials ensuring planning, execution, compliance, and delivery of trial milestones and KPIs. | Bachelor's degree with extensive project management experience in global clinical trials, strong leadership, communication, and strategic planning skills in complex matrix environments. | Senior Global Project Manager(Sponsor-Dedicated, Remote – US) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Senior Global Project Manager / Clinical Trial Leader (Sponsor-Dedicated, Remote – US) About the Role The Clinical Trial Leader (CTL), is a Senior Project Manager level role and serves as a key member of the sponsor’s Clinical Delivery Team, providing leadership, direction, and accountability across the full lifecycle of Phase I global clinical trials. This role ensures accurate planning, efficient execution, and delivery of trials that bring speed and value to participating subjects and sites. Operating across multi-country, global studies, the CTL provides strategic and operational oversight to ensure trials meet their defined milestones and key performance indicators (KPIs). The successful candidate will demonstrate strong scientific and operational expertise, outstanding communication, and the ability to influence across complex matrix environments. This is a sponsor-dedicated position supporting the experimental medicine team worldwide, with therapeutic area including Immunology. Candidates must have extensive Project Management experience in Phase I trials, specified therapeutic area (additional TA experience is a plus), and a 4-year undergraduate degree. What You Will Do: Trial Preparation Lead planning and operational feasibility assessments to ensure realistic and achievable trial timelines. Oversee trial set-up and ensure team alignment across functions including Statistics, Data Management, Medical Writing, and Site Monitoring. Support country allocation and feasibility processes; provide input to optimize site selection and trial readiness. Develop and implement trial-level engagement, recruitment, and risk mitigation plans, integrating patient and site feedback to enhance trial design and participant experience. Coordinate outsourcing of vendor services, supporting vendor identification, selection, and scope-of-work development. Partner with cross-functional teams to ensure readiness across all trial processes — clinical quality, safety monitoring, investigational product management, budgeting, and site support. Facilitate and support responses to regulatory authorities, ethics committees, and other external stakeholders. Ensure all trial team members receive appropriate study-specific and standardized training. Trial Conduct Maintain oversight of global clinical trial conduct to ensure compliance with Good Clinical Practice (GCP), internal SOPs, and all applicable regulatory requirements. Oversee patient recruitment progress, risk mitigation, and budget tracking to ensure efficient delivery. Manage amendments to study documentation and related retraining as needed. Ensure effective oversight of vendors and central labs, in collaboration with functional partners. Support ongoing communication and coordination across the clinical delivery network and stakeholders. For early-phase trials, coordinate activities related to biomarker sampling, genomics, and sub-studies. Trial Closeout and Reporting Oversee data cleaning and trial closeout activities, ensuring timely and accurate data delivery. Support clinical trial report (CTR) generation and results disclosure to global registries. Ensure proper archiving of all essential documents within the Trial Master File (TMF). Support scientific publication of trial outcomes where applicable. Strategic Contributions Contribute operational and scientific insight to trial and portfolio-level planning, supporting strategy alignment and risk mitigation. Ensure that key issues and insights are raised to the Evidence Team for timely resolution. Lead or support trial feasibility assessments that define critical design and execution parameters. What You Will Bring: Required Bachelor’s degree (4-year undergraduate degree) in a relevant field. Proven experience leading Phase II & III global clinical trials. Therapeutic area experience in Immunology, Metabolic, or Oncology (additional TA experience is a plus). Strong scientific and operational expertise across global clinical trial planning and execution. Exceptional leadership, communication, and stakeholder management skills in complex matrix structures. Ability to strategically plan and drive clinical trial delivery while ensuring patient-focused outcomes. Core Competencies Leadership & Influence: Inspire and empower cross-functional teams to deliver results, providing vision and direction. Strategic Mindset: Forward-thinking, analytical, and innovative — able to navigate ambiguity and align trial strategy with portfolio objectives. Project Management Excellence: Translate complex challenges into actionable solutions, anticipate risks, and ensure transparent execution. Coordination & Oversight: Prioritize activities, manage resources efficiently, and ensure consistent trial progress globally. Strong Communication: Culturally aware, transparent communicator capable of aligning global teams and external stakeholders. Why Join This Team: This is more than a project management role — it’s an opportunity to shape the delivery of transformative therapies on a global scale. As a Senior Global Project Manager / Clinical Trial Leader, you will connect science, strategy, and execution, ensuring every trial advances efficiently, ethically, and with meaningful impact for patients worldwide. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Lead and manage the delivery and scaling of technology-enabled Safety/Pharmacovigilance solutions, orchestrate partner ecosystems, drive portfolio planning, and lead innovation councils. | Hands-on leadership experience in Safety/Pharmacovigilance technology solutions, managing cross-functional teams and vendors, governance and compliance embedding, and strong communication skills for executive and customer engagement. | Job Description: • Build, deliver, and scale technology‑enabled Safety/Pharmacovigilance (PV) solutions • Orchestrates a partner ecosystem • Leads solutioning for RFIs/RFPs • Chairs customer innovation councils • Publishes points of view and presents at conferences/webinars • Manages a team and drives portfolio planning • Embeds risk‑based quality, privacy, and security Requirements: • A hands‑on leader to build, deliver, and scale technology‑enabled Safety/Pharmacovigilance (PV) solutions • Owns the roadmap and delivery of end to end SPVG solutions across case intake/processing, signal, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics • Leads cross‑functional execution with internal teams and external vendors/SIs; establishes governance, SLAs/KPIs, and validated deployments • Serves as solution lead on RFIs/RFPs: reference architectures, delivery models, scope/estimation, commercial constructs, and oral/bid defenses • Chairs customer innovation councils; converts problem statements into pilots/PoCs with clear success criteria • Publishes points of view, presents at conferences/webinars, and briefs executives on the PV tech landscape • Manages a small, senior team; drives portfolio planning, resourcing, budgets, and benefits realization • Embeds risk‑based quality, privacy, and security by design; partners closely with QA/Compliance and Data Privacy Benefits: • career development and progression • supportive and engaged line management • technical and therapeutic area training • peer recognition • total rewards program

Lead and manage complex Phase III oncology and hematology clinical trials, overseeing cross-functional teams, budgets, timelines, and client relationships to ensure successful project delivery. | Bachelor's degree in life sciences or related field, extensive Phase III oncology/hematology clinical trial experience, strong leadership of cross-functional teams, financial and vendor management expertise, and deep regulatory knowledge. | Senior Project Manager – Oncology/Hematology (Phase III) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Senior Project Manager – Oncology/Hematology (Phase III) Are you a seasoned CRO project leader passionate about advancing oncology and hematology research? Do you thrive in a fast-paced, collaborative environment where your leadership directly impacts patient outcomes? Join our team as a Senior Project Manager and take ownership of complex Phase III trials, driving projects from proposal through delivery and shaping the future of cancer care. About the Role: As a Senior Project Manager, you will take a lead role in advancing Phase III Oncology and Hematology clinical trials, managing complex, global initiatives. You’ll lead and inspire cross-functional teams, mentor emerging project managers, and act as the primary strategic partner for our clients, ensuring every milestone is delivered on time, on budget, and with exceptional quality. This role offers the opportunity to drive high-impact research that directly contributes to innovative cancer therapies and improved patient outcomes worldwide. What You’ll Do: Project Leadership & Delivery Drive the operational and financial success of Phase III clinical trials. Lead cross-functional teams across Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Affairs, Pharmacovigilance, and QA. Act as the primary liaison with clients, ensuring smooth project launch, conduct, and closeout. Oversee project deliverables, timelines, and budgets while proactively identifying and mitigating risks. Mentor junior project managers and project support staff, fostering collaboration and professional growth. Financial & Operational Accountability Own project budgets, forecasts, and financial performance. Ensure alignment and accountability across all vendors and study partners. Implement contingency plans and risk mitigation strategies to keep projects on track. Reporting & Communication Maintain and evaluate project progress using advanced tracking tools. Prepare and present project materials for internal and external stakeholders. Support inspection readiness and Trial Master File compliance. Business Development Participate in bid defense meetings as the potential project lead. Build strong client relationships to generate new opportunities. Stay up-to-date on oncology/hematology trends and the evolving drug development landscape. Management & Mentorship Train and mentor new project managers and clinical staff. Facilitate team communication, collaboration, and professional development. Who You Are: Experienced Global Project Leader (NA, LATAM, EMEA, and APAC) with strong Phase III CRO project management experience and a proven track record of delivering clinical trials successfully. Oncology and Hematology expertise, with direct experience leading complex Phase III trials. Cross-functional team leadership, overseeing such teams as Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Affairs, Pharmacovigilance, and Quality Assurance. Financially savvy, skilled in managing multi-million-dollar budgets, including creation, forecasting, and negotiation of out-of-scope work. Vendor management expertise, ensuring alignment, quality, and accountability across all study partners. Deep regulatory knowledge, with expertise in GCP/ICH guidelines and other applicable regulatory requirements. Educational foundation: Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Nursing, or a related field. Tech-forward, comfortable leveraging digital tools and emerging technologies to optimize project delivery. Strategic, results-driven leader with exceptional communication skills, able to navigate complex, dynamic environments while inspiring teams to achieve excellence. Why You’ll Love Working Here: Join a highly collaborative, innovative, and performance-driven team. Opportunities to mentor and be mentored, helping you grow professionally while developing others. Work on impactful global oncology and hematology trials, shaping the future of patient care. Thrive in an environment where innovation, growth, and professional development are actively encouraged. If you are ready to lead high-impact Phase III oncology and hematology clinical trials, drive innovation, and make a real difference in patient outcomes, we want to hear from you! At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Lead biomarker study operations and clinical project delivery by managing sample logistics, coordinating cross-functional teams, ensuring regulatory compliance, and maintaining operational excellence throughout clinical trials. | Significant experience managing biomarker studies and vendors, strong understanding of bioanalytical strategies in clinical trials, bachelor's degree in life sciences or related field, familiarity with GCP and ICH guidelines, strong project management skills, and willingness to travel up to 25%. | Job Description: • Lead Biomarker Study Operations • Oversee biomarker and bioanalytical activities across Sponsor and Collaborative programs • Serve as the operational point of contact for all biomarker-related processes • Work closely with clinical study teams (Phases 1–4) to integrate biomarker strategies into broader clinical development plans • Plan and manage the collection, tracking, and analysis of biological specimens • Advise study teams on best practices for sample management and logistics • Drive Clinical Project Delivery • Lead cross-functional teams through the full clinical trial lifecycle, from start-up to closeout • Ensure studies stay on track with respect to timelines, budget, scope, and quality • Act as the main liaison between the sponsor and study partners • Monitor and manage project financials, ensuring fiscal responsibility • Proactively identify and resolve operational issues and risks • Ensure Operational Excellence • Maintain high-quality documentation, including Trial Master File (TMF) accuracy and completeness • Keep study systems and databases current and audit-ready • Prepare project reports and updates for sponsors and internal stakeholders • Plan and facilitate internal and external meetings • Support inspection readiness and regulatory compliance throughout the project. Requirements: • Significant experience managing biomarker studies and external vendors required • Strong understanding of biomarker and bioanalytical strategies in a clinical trial setting • Proven ability to coordinate complex sample collection and analysis workflows • Expertise in supporting study teams with sample logistics and operational planning • Bachelor's degree in Life Sciences, Medicine, Pharmacy, Nursing, or equivalent combination of education and experience • Experience in a clinical research organization (CRO) or sponsor environment preferred • Familiarity with GCP, ICH guidelines, and global regulatory standards • Strong project management, organizational, and communication skills • Comfortable working independently and embracing new technologies • Willingness to travel up to 25% as needed. Benefits: • Health benefits to include Medical, Dental and Vision • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time • Company car or car allowance

Lead and oversee global Phase II and III clinical trials ensuring compliance, vendor coordination, and timely data delivery. | Bachelor's degree and proven experience leading Phase II & III global clinical trials in Immunology, Metabolic, or Oncology therapeutic areas with strong leadership and communication skills. | Job Description: • Serve as a key member of the sponsor’s Clinical Delivery Team, providing leadership, direction, and accountability across the full lifecycle of Phase II and III global clinical trials. • Ensure accurate planning, efficient execution, and delivery of trials that meet defined milestones and KPIs. • Coordinate outsourcing of vendor services, supporting vendor identification, selection, and scope-of-work development. • Maintain oversight of global clinical trial conduct to ensure compliance with Good Clinical Practice (GCP), internal SOPs, and all applicable regulatory requirements. • Oversee data cleaning and trial closeout activities, ensuring timely and accurate data delivery. Requirements: • Bachelor’s degree (4-year undergraduate degree) in a relevant field • Proven experience leading Phase II & III global clinical trials • Therapeutic area experience in Immunology, Metabolic, or Oncology (additional TA experience is a plus) • Strong scientific and operational expertise across global clinical trial planning and execution • Exceptional leadership, communication, and stakeholder management skills in complex matrix structures • Ability to strategically plan and drive clinical trial delivery while ensuring patient-focused outcomes. Benefits: • Health benefits to include Medical, Dental and Vision • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time

Lead and oversee global Phase II and III clinical trials ensuring planning, execution, compliance, and delivery of trial milestones and KPIs. | Bachelor's degree, extensive experience leading Phase II & III global clinical trials in Immunology, Metabolic, or Oncology, strong leadership and communication skills, and ability to manage complex matrix teams. | Senior Global Project Manager / Clinical Trial Leader (Sponsor-Dedicated, Remote – US) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Senior Global Project Manager / Clinical Trial Leader (Sponsor-Dedicated, Remote – US) About the Role The Clinical Trial Leader (CTL), is a Senior Project Manager level role and serves as a key member of the sponsor’s Clinical Delivery Team, providing leadership, direction, and accountability across the full lifecycle of Phase II and III global clinical trials. This role ensures accurate planning, efficient execution, and delivery of trials that bring speed and value to participating subjects and sites. Operating across multi-country, global studies, the CTL provides strategic and operational oversight to ensure trials meet their defined milestones and key performance indicators (KPIs). The successful candidate will demonstrate strong scientific and operational expertise, outstanding communication, and the ability to influence across complex matrix environments. This is a sponsor-dedicated position supporting in-house studies worldwide, with therapeutic areas including Immunology, Metabolic, and Oncology. Candidates must have extensive Project Management experience in Phase II & III trials, experience in at least one of the specified therapeutic areas (additional TA experience is a plus), and a 4-year undergraduate degree. What You Will Do: Trial Preparation Lead planning and operational feasibility assessments to ensure realistic and achievable trial timelines. Oversee trial set-up and ensure team alignment across functions including Statistics, Data Management, Medical Writing, and Site Monitoring. Support country allocation and feasibility processes; provide input to optimize site selection and trial readiness. Develop and implement trial-level engagement, recruitment, and risk mitigation plans, integrating patient and site feedback to enhance trial design and participant experience. Coordinate outsourcing of vendor services, supporting vendor identification, selection, and scope-of-work development. Partner with cross-functional teams to ensure readiness across all trial processes — clinical quality, safety monitoring, investigational product management, budgeting, and site support. Facilitate and support responses to regulatory authorities, ethics committees, and other external stakeholders. Ensure all trial team members receive appropriate study-specific and standardized training. Trial Conduct Maintain oversight of global clinical trial conduct to ensure compliance with Good Clinical Practice (GCP), internal SOPs, and all applicable regulatory requirements. Oversee patient recruitment progress, risk mitigation, and budget tracking to ensure efficient delivery. Manage amendments to study documentation and related retraining as needed. Ensure effective oversight of vendors and central labs, in collaboration with functional partners. Support ongoing communication and coordination across the clinical delivery network and stakeholders. For early-phase trials, coordinate activities related to biomarker sampling, genomics, and sub-studies. Trial Closeout and Reporting Oversee data cleaning and trial closeout activities, ensuring timely and accurate data delivery. Support clinical trial report (CTR) generation and results disclosure to global registries. Ensure proper archiving of all essential documents within the Trial Master File (TMF). Support scientific publication of trial outcomes where applicable. Strategic Contributions Contribute operational and scientific insight to trial and portfolio-level planning, supporting strategy alignment and risk mitigation. Ensure that key issues and insights are raised to the Evidence Team for timely resolution. Lead or support trial feasibility assessments that define critical design and execution parameters. What You Will Bring: Required Bachelor’s degree (4-year undergraduate degree) in a relevant field. Proven experience leading Phase II & III global clinical trials. Therapeutic area experience in Immunology, Metabolic, or Oncology (additional TA experience is a plus). Strong scientific and operational expertise across global clinical trial planning and execution. Exceptional leadership, communication, and stakeholder management skills in complex matrix structures. Ability to strategically plan and drive clinical trial delivery while ensuring patient-focused outcomes. Core Competencies Leadership & Influence: Inspire and empower cross-functional teams to deliver results, providing vision and direction. Strategic Mindset: Forward-thinking, analytical, and innovative — able to navigate ambiguity and align trial strategy with portfolio objectives. Project Management Excellence: Translate complex challenges into actionable solutions, anticipate risks, and ensure transparent execution. Coordination & Oversight: Prioritize activities, manage resources efficiently, and ensure consistent trial progress globally. Strong Communication: Culturally aware, transparent communicator capable of aligning global teams and external stakeholders. Why Join This Team: This is more than a project management role — it’s an opportunity to shape the delivery of transformative therapies on a global scale. As a Senior Global Project Manager / Clinical Trial Leader, you will connect science, strategy, and execution, ensuring every trial advances efficiently, ethically, and with meaningful impact for patients worldwide. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $114,000.00 - $210,900.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Lead and manage clinical development projects ensuring compliance with regulatory standards, coordinate teams, manage contracts and finances, and communicate project status to stakeholders. | Experience managing large-scale projects with minimal supervision, knowledge of Good Clinical Practices (GCPs), regulatory compliance, strong leadership, and communication skills. | Project Manager II - Sponsor Dedicated (North America-based) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Acts as a primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer's and Company's contractual agreement. Ensures the project is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. • Serves as the team leader by overseeing the project team. Facilitates team building and communication. Acts as a liaison and facilitator between other departments within the Company for project related tasks and/or issues. Proactively monitors project resources and works with functional lead/management to ensure project requirements are met. • Manages large scale projects encompassing various solutions ranging in complexity from single service regulatory and/or medical writing projects to large full scope multi-year projects, global projects and/or programs, with minimal interaction from supervisor. This includes proactive operational and financial management of tasks, risk, escalations, and quality from start-up through final deliverable. • Manages the executed contract and financial aspects of assigned projects/programs. Completes monthly review of tasks completed and backlog. Ensures customers are notified of out-of-scope items in a timely manner. • Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports. Ensures adequate documentation of each communication. • Independently prepares information for internal review meetings and proactively manages action resolution to ensure project delivery. • Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status and tracking reports as well as functional area plan, to appropriate team members and senior management. • Explores and champions new ideas for process and efficiency enhancements. • Networks to acquire new and/or repeat business across all regulatory and medical writing services. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $79,800.00 - $139,600.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Manage interdisciplinary clinical research projects ensuring compliance with GCP and regulatory requirements, lead project teams, oversee budgets and timelines, maintain study documentation, and coordinate with clients and partners. | Bachelor's degree or equivalent in life sciences or related field, CRO and therapeutic area experience preferred, strong knowledge of GCP/ICH guidelines, organizational and communication skills, and ability to travel approximately 25%. | Description Clinical Project Manager II - post-trial access / EAP / rollover studies Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Project Leadership and Delivery: • Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements. • Acts as a primary liaison between the Company and the Customer to ensure timely study launch,conduct, and closeout according to the Customer’s and the Company’s contractual agreement. • Lead project team to ensure quality, timelines and budget management. • Accountable for the financial performance of each project. • Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues. • Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. • Accountable for all project deliverables for each project assigned. Documentation and Reporting: • Responsible for quality and completeness of TMF for assigned projects. • Accountable for maintenance of study information on a variety of databases and systems. • Responsible for study management components of inspection readiness for all aspects of the study conduct. • Oversight for development and implementation of project plans. • Plan, coordinate and present at internal and external meetings. • Prepare project management reports for clients and management. • Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals. Business Development: • Develops strong relationships with current clients to generate new and/or add-on business for the future. • May participate in bid defense meetings where presented as potential project manager. Management: • May be required to line manage other project management team members and clinical monitoring staff. Qualifications • Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience. • Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements • Strong organizational skills. • Strong ability to manage time and work independently. • Direct therapeutic area expertise. • Ability to embrace new technologies. • Excellent communication, presentation, interpersonal skills, both written and spoken. • Ability to travel as necessary (approximately 25%). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Lead and manage complex medical writing projects ensuring documents meet regulatory and sponsor requirements, provide training and mentorship to medical editors, and perform copyediting and data integrity reviews. | Bachelor’s degree or equivalent experience in life sciences or related fields, strong copyediting and data integrity skills, familiarity with AMA style guide, knowledge of FDA/EU regulations, and ability to manage multiple projects independently. | Description Principal Medical Editor, Regulatory - Sponsor Dedicated (Home-based, Pacific Time Zone) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities • Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. • Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed. • Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk. • Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards. Provides training to members of the global Medical Writing team in aspects relative to their roles. • Project lead for deliverables of assigned complex and/or large medical writing projects, including but not limited to scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring that all information is distributed to the editorial team and implemented within the deliverable. • Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of document editorial process. • Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following American Medical Association (AMA) or various custom style guidelines as well as established medical writing internal checklists and best practices. • Performs data integrity review of assigned documents to ensure accuracy. • Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work. • Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget. • May compile and publish medical writing deliverables. Qualifications • Bachelor’s degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience. • Significant relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred; ISIToolbox experience preferred. • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). • Excellent attention to detail, including strong copyediting, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills. • Excellent grammatical and communication skills, both written and oral. • Extensive familiarity with the AMA style guide strongly preferred. • Ability to work with minimal supervision on multiple assignments with set deadlines. • Ability to work independently as well as part of a team and keep others informed of the progress and status of projects. • Adaptable to changes in work duties, responsibilities, and requirements. • Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Manage and lead a multifunctional clinical research team ensuring customer delivery, compliance, performance management, and resource allocation. | Bachelor’s degree or equivalent, extensive clinical research experience including leadership, knowledge of GCP/ICH guidelines, strong communication and organizational skills, and ability to travel. | Description Manager, FSP 360 Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Responsible for interacting and engaging with internal and external stakeholders for functional team members, acting as a Syneos Health ambassador with customers. Responsible for managing team members’ performance in line with project deliverables. Accountable for direct supervision of FSP360 multifunctional staff. Overall, the role will be responsible for three primary performance areas: • Customer Delivery and Success • Responsible for direct interaction with the customer points of contact (s) (PoC) on service delivery for their team members (direct reports). Develops and fosters strong, collaborative relationships with customers at a local level, promoting high levels of trust and satisfaction • Manages performance and daily activities of multifunctional team members to excel in service delivery and compliance with agreed-upon KPIs; develops and executes mitigation and remediation plans for non-compliance as needed • Participates in managing the resource availability for their team members to ensure they are suitably resourced and resource needs are identified in a timely fashion; resolves potential resourcing conflicts to facilitate mutually beneficial resolutions • Solicits feedback from customer PoC (s) for continuous improvement of service delivery and to strengthen customer relationships • Proactively communicates and manages customer issues through assigned escalation channels • Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCPs • May conduct oversight visits as required for Clinical Research Associates • Responsible for all system updates, and compliance to systems and relevant procedure and practices applicable to the customer and Syneos Health processes • Business Impact • Proactively discusses resource needs with customers, driving growth at a local account level • Makes informed and data-driven decisions of their team members that result in positive impact on overall business unit performance • Listens to customer and shares knowledge across the business unit in order to disseminate best practices and lessons learned in support of the overall FSP 360 operating model • Drives revenue by attracting, selecting and retaining the right talent • Continues to assess and places talent on projects leveraging core competencies, margin impact and alignment to customer requirements • Attends and participates in FSP360 account meetings as well as regional management team meetings and Town Halls • People Leadership • Provides line management to FSP360 team members • Responsible for active management of team members’ performance through the established Syneos Health process, including goal setting, mid-year reviews, year-end evaluations and implementation of performance improvement plans as necessary • Verifies that team members adhere to training guidelines, maintain their training records and individual and corporate training needs are identified and addressed • Provides administrative oversight (for example, HR processes, timecards, expense reports) • May be involved in assignment of project work and will review workload and utilization for all their team members • Supports team members’ professional development through coaching, providing opportunities to increase knowledge and skill levels, and by delegating tasks commensurate with skill level. Supporting and advocating for team members to develop their Individual Development Plans • Proactively works to ensure team members’ engagement, retention and turnover rates remain within expected levels. Recognizes team members while encouraging a culture of accountability • Demonstrates commitment to diversity, equity and inclusion through continuous development of all staff, modeling inclusive behaviors and proactively managing bias Qualifications • Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required. • Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirement • Excellent communication, presentation, interpersonal skills; both written and spoken, with an ability to inform, influence, convince, and persuade. • Strong time management, technical and organizational skills. Ability to work independently and within a team environment. • Creative problem solver who is self-motivated, flexible, open to change, collaborative, and possesses a customer-centric mindset • Knowledge of basic financial concepts as related to forecasting and budgeting. • Must demonstrate good computer skills and be able to embrace new technologies • Ability to travel as necessary (up to 25%) At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range $79,800.00 - $139,600.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Develop and maintain R-based data visualization apps, mentor biostatisticians, support statistical analysis and programming for clinical trials, and ensure quality and compliance of statistical deliverables. | PhD/MS in biostatistics or related field, 2+ years pharma/biotech statistician experience, expert in R and R-Shiny, knowledge of advanced programming and cloud technologies, strong communication skills. | Description Principal Biostatistician (Rshiny - EMEA & US BASED) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities • Please submit all CVs in English • Must be located in US, UK, Ireland, Poland, Spain, Greece, Hungary, Belgium, Romania, Ukraine, South Africa, Argentina, Mexico, Brazil, or Columbia. Principal Biostatistician - RShiny Specific Sets up and maintains excellent R-based computing environment. Adds missing features to apps and fixes bugs in existing apps. screens the market for supplied data visualization tools and integrates internal/external apps into our working environment. Organizes and performs user trainings and is available for user support on demand. Is up to date with the latest technical possibilities available on the global market. Excellent R and R-shiny knowledge thorough experience in clinical data structures and programming with data expert in functional and object-oriented programming. Knowledgeable in Javascript/Typescript, HTML, WebGL, experience in CUDA/GPU-programing, cloud-computing, Github, web-hosting/ Machine Learning. Strong communication skills and ability to work both, independently and collaboratively, clear in the presentation of complex issues. Job Responsibilities • Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel. • Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department. • Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR. • Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required. • May be responsible as Lead Biostatician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report. • Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. • Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis. • Implements company objectives, and creates alternative solutions to address business and operational challenges. • As biostatistics representative on project teams, interfaces with other departmental project team representatives • Preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. • Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications. • May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. • Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. • Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management. • Provides statistical programming support as needed. • May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs. • Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness. • Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business. • Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. • Performs other work-related duties as assigned. • Minimal travel may be required. Qualification Requirements • Previous Rshiny experience is required for this role. • PhD or MS in biostatistics, statistics, mathematics or data scientist with a strong emphasis on computing/informatics. • At least two years of experience as statistician with significant time spent in the Pharma, Biotech, or similar sector • Excellent R and R-shiny knowledge thorough experience in clinical data structures and programming with data • Expert in functional and object-oriented programming knowledgeable in Javascript/Typescript, HTML, WebGL • Experience in CUDA/GPU-programing, cloud-computing, Github, web-hosting • Strong communication skills and ability to work both, independently and collaboratively, clear in the presentation of complex issues • Team player • Fluency in English Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Principal Biostatistician - RShiny Specific: Sets up and maintains excellent R-based computing environment. Adds missing features to apps and fixes bugs in existing apps. screens the market for supplied data visualization tools and integrates internal/external apps into our working environment. Organizes and performs user trainings and is available for user support on demand. Is up to date with the latest technical possibilities available on the global market. Excellent R and R-shiny knowledge thorough experience in clinical data structures and programming with data expert in functional and object-oriented programming. Knowledgeable in Javascript/Typescript, HTML, WebGL, experience in CUDA/GPU-programing, cloud-computing, Github, web-hosting. Strong communication skills and ability to work both, independently and collaboratively, clear in the presentation of complex issues.

Manage site oversight, clinical and central monitoring, ensure patient safety and regulatory compliance, coordinate with clinical teams, and oversee deliverables and risk mitigation. | Bachelor's degree, 3+ years clinical trial management experience, knowledge of clinical research processes and regulations, strong project management and communication skills, proficiency with clinical trial software, and preferably CCRP certification. | Description Clinical Trial Manager I Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities • Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. • Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters. • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. • Participates and presents in key meetings such as Kick Off Meeting. • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution. • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data • Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required. • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and /or tracking tools. • Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans. • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. Provides solutions for obstacles in protocol execution and site management. • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA). Supports Inspection Readiness for clinical trial management scope. • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines. • Provides feedback to line managers on staff performance including strengths as well as areas for development. Qualifications • Bachelor's degree in a related field (e.g., life sciences, clinical research) • Minimum of 3 years of experience in clinical trial management or a related field • In-depth knowledge of clinical research processes and regulations • Strong project management and organizational skills • Excellent communication and interpersonal skills • Ability to work independently and as part of a team • Proficiency in using clinical trial management software and tools Certifications • Certified Clinical Research Professional (CCRP) or equivalent certification preferred Necessary Skills • Strong analytical and problem-solving skills • Attention to detail and accuracy • Ability to manage multiple projects and priorities simultaneously • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) • Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Clinical Trial Management job family at the P22 level. The Clinical Trial Manager I (CTM I) serves as the clinical functional lead, accountable for the delivery of site management, clinical monitoring and central monitoring of assigned study(ies). A CTM I is expected to independently manage the clinical and central monitoring team members but may serve as a regional clinical lead on larger trials under the direction of a global Sr CTM. The position as defined by scope provides leadership, problem-solving, mentoring, and technical support to the Clinical Operations team to ensure compliance with the monitoring plan as well as ensures timeliness and quality of deliverables within the specified budget.

Develop regulatory submissions and provide post-marketing regulatory support, including writing, research, compliance, and client advisory. | Senior level experience in regulatory submissions and compliance, strong writing and research skills, ability to manage smaller projects and support business development. | Description senior regulatory consultant Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Responsible for the development of regulatory submissions and post marketing regulatory support for clients. This includes authorship of portions of regulatory submissions, regulatory writing, regulatory research, and ensuring compliance with relevant guidelines and standards. Responsible for providing advice and assistance to clients and other associates in areas of expertise and may manage smaller client projects. Supports new business development in area of expertise. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Regulatory Submission Manager within the Vertex Regulatory Operations team.

Manage and prepare regulatory submissions and documentation, support regulatory agency interactions, and ensure compliance with global regulatory requirements. | Requires previous CMC experience, ability to manage regulatory submissions, support audits, and work within EST time zone. | Description Regulatory Consultant CMC Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities For non-complex and complex submissions, independently fulfill the following responsibilities: • Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. • Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions. • Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies. • Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle. • Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems. • Prepare estimates for conducting regulatory services as part of single or multiple service proposals. • Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities. • Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes. • Prepare training materials and share best practices in the regulatory area, both internally and externally. • Participate as regulatory support in internal or external project audits. • Participate as regulatory support on internal cross-functional initiatives. • Contribute to the creation and/or maintenance of SOPs and other process related documentation as required. • Provide support in oversight to team members in the execution of their project responsibilities. • Capable of identifying when to ensure line support required to provide additional guidance and direction. • Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range $56,400.00 - $95,900.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary • Previous CMC experience is required. *Open to all of North America, but must agree to work EST zone.