Parexel

Provide operational and technical support for outsourced chemistry projects with external partners, including project tracking and vendor performance monitoring. | Degree in chemistry or related field with 3-10+ years pharmaceutical experience, synthetic chemistry background, communication skills, and either Mandarin fluency or project/vendor management experience. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Principal Scientist I or II - Synthetic Chemist position working as a full-time employee of Parexel FSP on long-term remote assignment for one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. Description The role is within the External Capabilities group in Small Molecule Process R&D. Provides operational support and technical guidance for outsourced projects within Merck’s external CDMO partners to ensure the on time, high quality delivery of products and services. Some flexibility is required to work remotely with Merck’s overseas partners in another time zone during off hours (e.g., occasionally checking and responding to emails, discussions with the overseas team, in the evening as needed). This role will be mostly remote and on-site in Rahway, NJ when necessary. Qualifications • Education: Degree in chemistry, or a related discipline • Principal Scientist 1: PhD or MS with 3+ years of experience, or BS with 7+ years of experience • Principal Scientist 2: PhD with 1-3 years of experience, or MS with 5+ years, or BS with 10+ years • MS with 3+ years of pharmaceutical industry experience Required Skills and Experience • Synthetic chemistry background • Ability to quickly learn new things • Strong verbal and written communication skills • At least one of the following is required: • Fluency in Mandarin • Previous experience in project management and vendor management Desired Skills and Experience • Familiar with Microsoft Office suite, ChemDraw and ELN • Fluency in Mandarin (preferred) • Previous experience in project management and vendor management is a plus Responsibilities • Providing the operational support for chemistry sourcing projects with external partners • Providing technical guidance on sourcing projects when appropriate • Preparing technical packages • Issuing POs, processing invoices • Ensuring fast shipping • Monitoring vendor performance • Maintaining Microsoft Teams sites and SharePoint sites, and tracking project progress About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

The Senior Clinical Research Associate (Sr. CRA) is responsible for site management, monitoring, and close-out of assigned clinical trial investigator sites to ensure patient safety and quality study execution. The Sr. CRA manages investigator site relationships and resolves protocol-related issues while ensuring compliance with applicable laws and Good Clinical Practices. | Candidates should have a minimum of 3 years of relevant experience in clinical research site monitoring, preferably with 2 years in Oncology. A bachelor's degree in life sciences or a professional degree in a related field is required. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. Monitoring Responsibilities and Study Conduct: Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities Support database release as needed May undertake the responsibilities of an unblinded monitor where appropriate Clinical/Scientific and Site Monitoring Risk: Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators Drive Quality Event (QE) remediation, when applicable Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable Skills: Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases Must be fluent in English and in the native language(s) of the country they will work in Ability to travel 60-80% Valid driver’s license and passport required Education: Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent #LI-LO1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

Provide operational support and technical guidance for outsourced chemistry projects, manage vendor relationships, and ensure timely delivery of products and services. | Degree in chemistry or related field with significant pharmaceutical industry experience, strong synthetic chemistry skills, and at least one of fluency in Mandarin or project/vendor management experience. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Principal Scientist I or II - Synthetic Chemist position working as a full-time employee of Parexel FSP on long-term remote assignment for one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. Description The role is within the External Capabilities group in Small Molecule Process R&D. Provides operational support and technical guidance for outsourced projects within Merck’s external CDMO partners to ensure the on time, high quality delivery of products and services. Some flexibility is required to work remotely with Merck’s overseas partners in another time zone during off hours (e.g., occasionally checking and responding to emails, discussions with the overseas team, in the evening as needed). This role will be mostly remote and on-site in Rahway, NJ when necessary. Qualifications Education: Degree in chemistry, or a related discipline Principal Scientist 1: PhD or MS with 3+ years of experience, or BS with 7+ years of experience Principal Scientist 2: PhD with 1-3 years of experience, or MS with 5+ years, or BS with 10+ years MS with 3+ years of pharmaceutical industry experience Required Skills and Experience Synthetic chemistry background Ability to quickly learn new things Strong verbal and written communication skills At least one of the following is required: Fluency in Mandarin Previous experience in project management and vendor management Desired Skills and Experience Familiar with Microsoft Office suite, ChemDraw and ELN Fluency in Mandarin (preferred) Previous experience in project management and vendor management is a plus Responsibilities Providing the operational support for chemistry sourcing projects with external partners Providing technical guidance on sourcing projects when appropriate Preparing technical packages Issuing POs, processing invoices Ensuring fast shipping Monitoring vendor performance Maintaining Microsoft Teams sites and SharePoint sites, and tracking project progress About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

The role involves providing operational support and technical guidance for outsourced projects within Merck’s external CDMO partners. Responsibilities include preparing technical packages, issuing POs, processing invoices, and monitoring vendor performance. | Candidates must have a degree in chemistry or a related discipline, with varying experience levels depending on the position. A synthetic chemistry background and strong communication skills are essential, with fluency in Mandarin preferred. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Principal Scientist I or II - Synthetic Chemist position working as a full-time employee of Parexel FSP on long-term assignment hybrid for one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. Description The role is within the External Capabilities group in Small Molecule Process R&D. Provides operational support and technical guidance for outsourced projects within Merck’s external CDMO partners to ensure the on time, high quality delivery of products and services. Some flexibility is required to work remotely with Merck’s overseas partners in another time zone during off hours (e.g., occasionally checking and responding to emails, discussions with the overseas team, in the evening as needed). This role will be mostly remote and on-site in Rahway, NJ when necessary. Qualifications Education: Degree in chemistry, or a related discipline Principal Scientist 1: PhD or MS with 3+ years of experience, or BS with 7+ years of experience Principal Scientist 2: PhD with 1-3 years of experience, or MS with 5+ years, or BS with 10+ years MS with 3+ years of pharmaceutical industry experience Required Skills and Experience Synthetic chemistry background Ability to quickly learn new things Strong verbal and written communication skills At least one of the following is required: Fluency in Mandarin Previous experience in project management and vendor management Desired Skills and Experience Familiar with Microsoft Office suite, ChemDraw and ELN Fluency in Mandarin (preferred) Previous experience in project management and vendor management is a plus Responsibilities Providing the operational support for chemistry sourcing projects with external partners Providing technical guidance on sourcing projects when appropriate Preparing technical packages Issuing POs, processing invoices Ensuring fast shipping Monitoring vendor performance Maintaining Microsoft Teams sites and SharePoint sites, and tracking project progress About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

Provide operational support and technical guidance for outsourced chemistry projects, manage vendor relations, prepare technical packages, and monitor project progress. | Degree in chemistry or related field with 7-10+ years of relevant experience, synthetic chemistry background, strong communication skills, and at least one of fluency in Mandarin or project/vendor management experience. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Principal Scientist I or II - Synthetic Chemist position working as a full-time employee of Parexel FSP on long-term assignment hybrid for one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. Description The role is within the External Capabilities group in Small Molecule Process R&D. Provides operational support and technical guidance for outsourced projects within Merck’s external CDMO partners to ensure the on time, high quality delivery of products and services. Some flexibility is required to work remotely with Merck’s overseas partners in another time zone during off hours (e.g., occasionally checking and responding to emails, discussions with the overseas team, in the evening as needed). This role will be mostly remote and on-site in Rahway, NJ when necessary. Qualifications Education: Degree in chemistry, or a related discipline Principal Scientist 1: PhD or MS with 3+ years of experience, or BS with 7+ years of experience Principal Scientist 2: PhD with 1-3 years of experience, or MS with 5+ years, or BS with 10+ years MS with 3+ years of pharmaceutical industry experience Required Skills and Experience Synthetic chemistry background Ability to quickly learn new things Strong verbal and written communication skills At least one of the following is required: Fluency in Mandarin Previous experience in project management and vendor management Desired Skills and Experience Familiar with Microsoft Office suite, ChemDraw and ELN Fluency in Mandarin (preferred) Previous experience in project management and vendor management is a plus Responsibilities Providing the operational support for chemistry sourcing projects with external partners Providing technical guidance on sourcing projects when appropriate Preparing technical packages Issuing POs, processing invoices Ensuring fast shipping Monitoring vendor performance Maintaining Microsoft Teams sites and SharePoint sites, and tracking project progress About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

Manage and negotiate clinical trial contracts and agreements, ensure compliance with legal standards, and support contract administration and operational management. | At least 5 years of site contracting experience in CRO or pharma, expertise in negotiating CDAs, CTAs, ICFs, and familiarity with contract management systems and relevant legal regulations. | External Job Description Job Summary: The Contracts Manager, Research and Development Legal will be responsible for providing contract management to support clinical trials. Key Accountabilities: Contract Negotiations and Reviews • Review and negotiate Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), and Informed Consent Forms (ICFs), either directly or as escalated by Contract Research Organizations (CROs) • Identify and escalate contract terms to appropriate contract owners, attorneys, and other appropriate stakeholders, in a timely manner • Build strong working relationships with CRO contracting staff (including contracting staff at medical institutions) to facilitate quick contract executions and conflict resolutions ensuring efficient conduct of clinical trials Track and drive contracts to execution, including identifying remaining contracting issues, identifying appropriate stakeholders to reach decisions and convening meetings to drive efficient decision-making • Identify and effectively communicate priorities and urgencies to applicable stakeholders • Participate in cross-functional teams to ensure contract executions and strategies are achieving targeted goal Contract Administration / Operational Management • Serve as an expert in client Contract Management System (CMS) and processes • Work closely with Legal Operations and the CMS teams to ensure contracts are properly managed in the system and develop enhancements, improvements and updates • Partner with Legal and other colleagues to address and solve day-to-day contracting issues and proactively troubleshoot and implement short-term and long-term contract improvements and efficiencies • Support and manage contract templates and guidelines, as requested; track negotiated terms across agreements and identify potential updates to contracting guidelines • Propose updated contracting guidelines, as needed Compliance with Parexel Standards • Complies with required training curriculum • Completes timesheets accurately and timely as required • Submits expense reports as required • Updates CV as required • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: • General understanding of applicable laws and regulations as well as legal risks that might impact research and development of a commercial-stage biotech company (including confidentiality, intellectual property, anti-kickback/anti-bribery laws, FDA regulations, and privacy laws) • Strong written, oral communication, interpersonal, and organizational skills • Ability to work independently as well as in a team environment • Ability to effectively prioritize workload and communicate priorities • Ability to work and adapt in a complex and dynamic organization handling multi-faceted projects with tight timelines • Ability to interact effectively and productively with all levels within an organization in a calm and professional manner • Motivated to work in a fast-paced environment • Detail oriented Knowledge and Experience: • Minimum 5 years of site contracting experience in a CRO or pharma setting • Experience negotiating CDAs, CTAs, and ICFs, either in a pharmaceutical/biotech company or CRO • Experience negotiating with a Contract Management System (CMS) required • ICF review experience is preferred #LI-CF1 #LI-REMOTE

Lead patient safety projects by managing cross-functional teams, client relationships, budgets, and compliance to ensure high-quality pharmacovigilance deliverables. | Requires 5+ years in drug development or healthcare with extensive pharmacovigilance experience, project management skills, and knowledge of clinical adjudication and safety database platforms. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Shape the Future of Patient Safety at Parexel Are you a strategic thinker with a passion for patient safety and project leadership? Parexel is seeking a dynamic Patient Safety Project Lead (PSPL) to spearhead high-impact safety initiatives across full-service, functional, and standalone projects. This pivotal role blends strategic oversight with hands-on leadership, driving client satisfaction, optimizing resources, and ensuring top-tier quality and compliance in every facet of patient safety. As a PSPL, you’ll be the connective force between cross-functional teams, sponsor stakeholders, and medical experts—serving as the primary liaison on full-service projects and collaborating closely with the Global Lead Physician. Whether guiding Clinical Adjudication Committees (CAC), supporting Data Monitoring Committees (DMC), or leading specialized safety scopes, you’ll be at the forefront of regulatory excellence and operational innovation. Client Liaison & Service Excellence • Supports establishment of collaborative client relationships that foster trust, efficiency, and professional engagement • Implement data-driven performance metrics and key performance indicators to quantitatively measure success and drive continuous improvement for assigned projects • Proactively address client concerns, providing timely solutions and feedback to safety services management • Contribute knowledge to proposal development for standalone through end-to-end safety services • Assess service scope requirements, providing detailed task descriptions and resource estimations • Represent Parexel patient safety services at business development meetings, bid defenses, and client governance forums as needed Project Management Mastery • Develop and maintain comprehensive project plans with clear milestones, deliverables, and timelines • Monitor task progression and overall program performance, implementing corrective actions as needed • Facilitate transparent communication regarding project status to clients and internal stakeholders • Conduct regular financial oversight, comparing actual versus planned budgets and optimizing resource utilization • Provide forecasting to patient safety services management, proposing innovative solutions for timeline shifts and staffing requirements • Ensure proper scope change management to maintain project profitability • Oversee revenue recognition, forecasting activities, and contractual invoicing for small standalone projects, or supports these activities proactively for full-service projects • Serve as primary point of contact for financial matters, coordinating with Project Analysts, related to patient safety services • Represent patient safety services during external audits, addressing findings and implementing improvements Cross-Functional Collaboration • Coordinate seamlessly with internal teams (e.g., Business Operations, Clinical Operations, Data Management, Safety technology) • Manage relationships with external patient safety stakeholders (clients, vendors, health authorities) • Provide expert guidance on process-related issues in accordance with ICH, FDA, EMA, and other applicable guidelines • Partner with Subject Matter Experts to enhance quality, efficiency, and project management methodologies • Quality & Compliance Leadership • Ensure consistent delivery of high-quality deliverables that meet or exceed client expectations • Stay current with industry advances, regulatory updates, and emerging trends in patient safety • Apply in-depth knowledge of pharmacovigilance systems and regulatory requirements • Maintain compliance with ICH, GCP, and relevant geographic regulations General • Foster a positive, results-oriented work environment that emphasizes partnership and teamwork • Communicate openly, transparently, and objectively with team members • Provide leadership and coverage during management absences • May supervise direct reports and provide functional oversight across the SBU when required Skills: • Leadership abilities with demonstrated success in building effective project teams • Strong motivational skills with proven ability to delegate effectively and make quality decisions • Proficient knowledge of pharmacovigilance technology and systems and safety database management • Familiarity with business operating procedures including contract management, revenue recognition, and project lifecycle management • Effective budget planning and financial management experience • Ability to prioritize effectively and manage multiple projects simultaneously • Collaborative mindset with demonstrated success in matrix environments • Proactive problem-solving approach with ability to create appropriate sense of urgency • Strong understanding of clinical research processes and drug development lifecycle • Robust written and verbal communication skills Knowledge and Experience: • Extensive drug safety knowledge with substantial experience in pharmacovigilance • Minimum 5+ years working in drug development and/or healthcare environments • Proven project management experience with demonstrated team leadership capabilities • Strong command of written and spoken English; additional language proficiency as required • Established track record of developing and maintaining client relationships • Specialized experience in clinical adjudication and data monitoring committee processes, specifically for CAC and DMC projects management • Proficiency with IDRA workflows, committee governance, and adjudication technology platforms, specifically for CAC and DMC projects management • Comprehensive understanding of pharmacovigilance systems and regulatory requirements Education: • Degree in Pharmacy, Nursing, Life Science, or other health-related field, or relevant work experience in Pharmacovigilance. • A certification in project management is an advantage. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Lead patient safety projects by managing cross-functional teams, client relationships, budgets, compliance, and quality assurance in pharmacovigilance and clinical adjudication contexts. | 5+ years in drug development or healthcare with pharmacovigilance experience, project management skills, knowledge of clinical adjudication and data monitoring committees, and relevant health-related degree or experience. | Shape the Future of Patient Safety at Parexel Are you a strategic thinker with a passion for patient safety and project leadership? Parexel is seeking a dynamic Patient Safety Project Lead (PSPL) to spearhead high-impact safety initiatives across full-service, functional, and standalone projects. This pivotal role blends strategic oversight with hands-on leadership, driving client satisfaction, optimizing resources, and ensuring top-tier quality and compliance in every facet of patient safety. As a PSPL, you'll be the connective force between cross-functional teams, sponsor stakeholders, and medical experts-serving as the primary liaison on full-service projects and collaborating closely with the Global Lead Physician. Whether guiding Clinical Adjudication Committees (CAC), supporting Data Monitoring Committees (DMC), or leading specialized safety scopes, you'll be at the forefront of regulatory excellence and operational innovation. Client Liaison & Service Excellence • Supports establishment of collaborative client relationships that foster trust, efficiency, and professional engagement • Implement data-driven performance metrics and key performance indicators to quantitatively measure success and drive continuous improvement for assigned projects • Proactively address client concerns, providing timely solutions and feedback to safety services management • Contribute knowledge to proposal development for standalone through end-to-end safety services • Assess service scope requirements, providing detailed task descriptions and resource estimations • Represent Parexel patient safety services at business development meetings, bid defenses, and client governance forums as needed Project Management Mastery • Develop and maintain comprehensive project plans with clear milestones, deliverables, and timelines • Monitor task progression and overall program performance, implementing corrective actions as needed • Facilitate transparent communication regarding project status to clients and internal stakeholders • Conduct regular financial oversight, comparing actual versus planned budgets and optimizing resource utilization • Provide forecasting to patient safety services management, proposing innovative solutions for timeline shifts and staffing requirements • Ensure proper scope change management to maintain project profitability • Oversee revenue recognition, forecasting activities, and contractual invoicing for small standalone projects, or supports these activities proactively for full-service projects • Serve as primary point of contact for financial matters, coordinating with Project Analysts, related to patient safety services • Represent patient safety services during external audits, addressing findings and implementing improvements Cross-Functional Collaboration • Coordinate seamlessly with internal teams (e.g., Business Operations, Clinical Operations, Data Management, Safety technology) • Manage relationships with external patient safety stakeholders (clients, vendors, health authorities) • Provide expert guidance on process-related issues in accordance with ICH, FDA, EMA, and other applicable guidelines • Partner with Subject Matter Experts to enhance quality, efficiency, and project management methodologies • Quality & Compliance Leadership • Ensure consistent delivery of high-quality deliverables that meet or exceed client expectations • Stay current with industry advances, regulatory updates, and emerging trends in patient safety • Apply in-depth knowledge of pharmacovigilance systems and regulatory requirements • Maintain compliance with ICH, GCP, and relevant geographic regulations General • Foster a positive, results-oriented work environment that emphasizes partnership and teamwork • Communicate openly, transparently, and objectively with team members • Provide leadership and coverage during management absences • May supervise direct reports and provide functional oversight across the SBU when required Skills: • Leadership abilities with demonstrated success in building effective project teams • Strong motivational skills with proven ability to delegate effectively and make quality decisions • Proficient knowledge of pharmacovigilance technology and systems and safety database management • Familiarity with business operating procedures including contract management, revenue recognition, and project lifecycle management • Effective budget planning and financial management experience • Ability to prioritize effectively and manage multiple projects simultaneously • Collaborative mindset with demonstrated success in matrix environments • Proactive problem-solving approach with ability to create appropriate sense of urgency • Strong understanding of clinical research processes and drug development lifecycle • Robust written and verbal communication skills Knowledge and Experience: • Extensive drug safety knowledge with substantial experience in pharmacovigilance • Minimum 5+ years working in drug development and/or healthcare environments • Proven project management experience with demonstrated team leadership capabilities • Strong command of written and spoken English; additional language proficiency as required • Established track record of developing and maintaining client relationships • Specialized experience in clinical adjudication and data monitoring committee processes, specifically for CAC and DMC projects management • Proficiency with IDRA workflows, committee governance, and adjudication technology platforms, specifically for CAC and DMC projects management • Comprehensive understanding of pharmacovigilance systems and regulatory requirements Education: • Degree in Pharmacy, Nursing, Life Science, or other health-related field, or relevant work experience in Pharmacovigilance. • A certification in project management is an advantage. #LI-LB1 #LI-REMOTE

The Senior Precision Medicine Associate collaborates with cross-functional study teams to implement Precision Medicine goals within clinical trials. They manage central laboratory and specialty vendors and ensure optimal clinical trial execution. | Candidates should have a minimum of 6 years of relevant industry experience and a science background with knowledge of medical terms and biological assays. A Bachelor of Science degree in Biology or a related field is preferred. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel FSP has an exciting opportunity for a Senior Precision Medicine Associate. This role works closely with line Manager, Precision Medicine, and other key personnel to implement and operationalize Precision Medicine goals within client clinical trials. Manages central laboratory and specialty vendors on low to moderately complex clinical trials. Performs other duties as necessary to ensure optimal clinical trial execution. Key Accountabilities: Study Team Support Collaborates within cross functional study teams Presents at investigator meetings and creates training materials (lab manual, sample collection procedures and presentation slides) Manages acquisition of clinical trial samples Provides support for sample related matters to clinical study teams Works with Informed Consent Form (ICF) Specialist and Precision Medicine Operations Lead (PMOL) to ensure compliance with ICF permissions Operational Support of Biomarker and Exploratory Analysis Assists PMOL with vendor selection and oversight Executes biomarker plans in collaboration with the study team and PMOL Provides input to clinical trial related documents under the supervision of the PMOL Selection of Central Laboratory and Specialty Vendors Prepares Request for Proposal (RFP), reviews and assesses bids and statements of work Manages biomarker vendors for low to moderately complex clinical trials Coordinates capabilities presentations by third party vendors Central Laboratory and Specialty Vendors Management Communicates with academic collaborators Participates in oversight activities with vendors and supports audits as required Data Acquisition and Management Supports information exchange and maintains data integrity Provides guidance and training to clinical sites, collaborators and vendors under supervision of the PMOL Supports sample and data reconciliation activities Compliance with Parexel standards Complies with timely completion of required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: Effective problem-solving skills with internal and external stakeholders Comfortable presenting to internal and external audiences Proficient in written and spoken English required Proficient in local language, as applicable, preferred Project management and organizational skills Ability to effectively multi-task and prioritize Ability to work in a global matrix environment Proficiency in widely used technologies and ability to learn client applications (especially Microsoft Excel) Problem solving abilities, troubleshooting, resourcefulness, and attention to detail Knowledge and Experience: Minimum of 6 years relevant industry experience is required Science background and working knowledge of a wide array of medical terms, biological assays including proteomics, cellular assays and genomics Understanding of bioethics of human biospecimen collection and research May require oncology experience Education: Bachelor of Science degree or equivalent Biology or equivalent major preferred EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

The Metrology Specialist is responsible for overseeing the lifecycle of laboratory instrumentation, including acquisition, installation, maintenance, and validation. This role also involves ensuring compliance with regulatory requirements and representing the laboratory during audits. | Candidates must have a B.S. or M.S. in Chemistry, Biochemistry, Engineering, or a related discipline, with relevant experience depending on the level applied for. Experience in a regulated laboratory and familiarity with laboratory equipment maintenance and validation is required. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Scientist II or III - Metrology Specialist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. Metrology specialist is responsible for the oversight of regulated and non-regulated laboratory equipment. This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement Qualifications – B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline Scientist II - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years of relevant experience Scientist III - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience Responsibilities Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities Participate in computer system validation activities associated with new or upgraded equipment or software packages Support the purchase, installation, and equipment qualification of new laboratory equipment Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support Originate and progress Notice of Event (NOE) and Change Management (CM) records Perform and document investigations and assist in developing/implementing CAPA plans Represent the laboratory on all aspects of laboratory equipment during audits Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures Required Skills and Experience Experience working within a regulated (GMP) laboratory Experience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems Familiarity with standalone computer system validation requirements Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks Capable of working independently under moderate supervision Strong verbal and written communication skills Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators Desired Skills and Experience Experience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them. Experience with computerized standalone systems GMP validation requirements Familiarity with authoring relevant instrument standard operating procedures (SOPs) About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

The Metrology Specialist is responsible for overseeing the lifecycle of laboratory instrumentation, including acquisition, installation, maintenance, and validation. This role also involves ensuring compliance with regulatory requirements and supporting process improvements across multiple labs. | Candidates must have a B.S. or M.S. in Chemistry, Biochemistry, Engineering, or a related discipline, with relevant experience depending on the level applied for. Experience in a regulated laboratory environment and familiarity with laboratory equipment maintenance and validation is required. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Scientist II or III - Metrology Specialist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. Metrology specialist is responsible for the oversight of regulated and non-regulated laboratory equipment. This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement Qualifications – B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline Scientist II - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years of relevant experience Scientist III - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience Responsibilities Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities Participate in computer system validation activities associated with new or upgraded equipment or software packages Support the purchase, installation, and equipment qualification of new laboratory equipment Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support Originate and progress Notice of Event (NOE) and Change Management (CM) records Perform and document investigations and assist in developing/implementing CAPA plans Represent the laboratory on all aspects of laboratory equipment during audits Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures Required Skills and Experience Experience working within a regulated (GMP) laboratory Experience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems Familiarity with standalone computer system validation requirements Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks Capable of working independently under moderate supervision Strong verbal and written communication skills Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators Desired Skills and Experience Experience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them. Experience with computerized standalone systems GMP validation requirements Familiarity with authoring relevant instrument standard operating procedures (SOPs) About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

The Senior Precision Medicine Associate will collaborate with cross-functional study teams to implement Precision Medicine goals within clinical trials. They will manage laboratory and specialty vendors and ensure optimal execution of clinical trials. | Candidates should have a minimum of 6 years of relevant industry experience and a science background with knowledge of medical terms and biological assays. A Bachelor of Science degree in Biology or a related field is preferred. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel FSP has an exciting opportunity for a Senior Precision Medicine Associate. This role works closely with line Manager, Precision Medicine, and other key personnel to implement and operationalize Precision Medicine goals within client clinical trials. Manages central laboratory and specialty vendors on low to moderately complex clinical trials. Performs other duties as necessary to ensure optimal clinical trial execution. Key Accountabilities: Study Team Support Collaborates within cross functional study teams Presents at investigator meetings and creates training materials (lab manual, sample collection procedures and presentation slides) Manages acquisition of clinical trial samples Provides support for sample related matters to clinical study teams Works with Informed Consent Form (ICF) Specialist and Precision Medicine Operations Lead (PMOL) to ensure compliance with ICF permissions Operational Support of Biomarker and Exploratory Analysis Assists PMOL with vendor selection and oversight Executes biomarker plans in collaboration with the study team and PMOL Provides input to clinical trial related documents under the supervision of the PMOL Selection of Central Laboratory and Specialty Vendors Prepares Request for Proposal (RFP), reviews and assesses bids and statements of work Manages biomarker vendors for low to moderately complex clinical trials Coordinates capabilities presentations by third party vendors Central Laboratory and Specialty Vendors Management Communicates with academic collaborators Participates in oversight activities with vendors and supports audits as required Data Acquisition and Management Supports information exchange and maintains data integrity Provides guidance and training to clinical sites, collaborators and vendors under supervision of the PMOL Supports sample and data reconciliation activities Compliance with Parexel standards Complies with timely completion of required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: Effective problem-solving skills with internal and external stakeholders Comfortable presenting to internal and external audiences Proficient in written and spoken English required Proficient in local language, as applicable, preferred Project management and organizational skills Ability to effectively multi-task and prioritize Ability to work in a global matrix environment Proficiency in widely used technologies and ability to learn client applications (especially Microsoft Excel) Problem solving abilities, troubleshooting, resourcefulness, and attention to detail Knowledge and Experience: Minimum of 6 years relevant industry experience is required Science background and working knowledge of a wide array of medical terms, biological assays including proteomics, cellular assays and genomics Understanding of bioethics of human biospecimen collection and research May require oncology experience Education: Bachelor of Science degree or equivalent Biology or equivalent major preferred EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

Manage clinical sample operations and data integration to support biomarker evaluation and ensure compliance with protocols and budgets. | 6-8 years clinical research experience, knowledge of clinical trials and databases, bachelor’s degree in life sciences or nursing, strong communication and project management skills. | Works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM) groups to ensure quality samples and data are delivered to support biomarker and non-biomarker evaluation and enable the translation of science to medicine. Will work closely with project managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries. Additional responsibilities include overall project management in alignment with the core business strategy. Operations Management Study Team Support • Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders, such as working with Informed Consent Form (ICF) specialist in SKDL on ICF and other trial documents impacting samples and testing Operational Support of Sample Analysis (including exploratory analysis) • Establishment, oversight, planning, and integration of all issues related to collection, processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations • Liaises with Precision Medicine Strategy Leads and other scientists by assessing vendors, forecasting sample operational costs, timelines and reviewing invoices to ensure alignment with budget plans Data Acquisition and Management • Works closely with data management lead to determine how sample and testing data will be captured, blinded and transferred for clinical trials Human Sample Management Flow and Compliance • Provides guidance to clinical teams and clinical sites regarding collection, storage, and shipping of samples acquired in the course of clinical trials or other human sample acquisition projects • Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF • Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed Compliance with Parexel Standards • Complies with required training curriculum • Completes timesheets accurately as required • Submits expense reports as required • Updates CV as required • Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery Skills: • Excellent written and verbal communication skills • Resolve problems spontaneously and possess strong project management and organizational skills • Work independently and proactively while still contributing to group initiatives and goals • Good interpersonal skills and ability to work with many different groups/teams • Microsoft applications Knowledge and Experience: 6 - 8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry. We are seeking a professional with working knowledge of clinical trials and clinical databases. Laboratory sample management experience is a plus. Education: Bachelor’s degree in a life science, nursing qualification or other relevant experience required. #LI-REMOTE

Lead and oversee clinical trial operational activities including vendor management, regulatory compliance, budgeting, and stakeholder coordination to ensure successful study execution. | Requires 5+ years clinical research experience with CRO/biotech/pharma, 2-3 years leading global clinical trials, CRO management experience, and a bachelor's degree. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Summary: The Clinical Operations Leader is responsible for the execution of study-level activities including but not limited to creating and updating trial-specific documents, vendor oversight & delivery, compound training and country and regional oversight of CRO operational delivery. This includes alignment on the feasibility strategy, target setting, risk reviews, and country challenges that could impact overall study delivery. Key Accountabilities: Oversight of Project Cycle • Manage integration of project team activities • Manage strategic study operations including but not limited to study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, budget and financial information, performance metrics, and data flow • Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specific studies • Provide input into global subject/patient recruitment plans • Manage aspects of CRO/vendor identification and the day-to-day operational management activities of CROs and other vendors including set up, statement of work creation, and budget oversight • Create and update critical trial-specific documents • Support development of compound and protocol level training materials • Review and provide input into budgets, timelines, and forecasts for assigned clinical studies • Provide support for inspection readiness activities including risk identification and mitigation plans at the trial level • Participate in process improvement activities at a trial and department level as needed Collaborative Relationships • Manage relationships between study sites and vendors • Interface with internal key stakeholders • Support onboarding of new team members • Attend stakeholder meetings and provide input and updates on operational activities and progress Compliance with Parexel Standards • Complies with required training curriculum • Completes timesheets accurately and timely as required • Submits expense reports as required • Updates CV as required • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: • Excellent decision-making, analytical, and financial management skills • Excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision • Experience in leading without authority and in multifunctional matrixed and global environments • Experience mentoring and coaching others • Exceptional organizational skills and ability to deal with competing priorities • Strong reasoning and problem-solving abilities • Strong project planning/management, communications (written and verbal) and presentation skills • Experience with protocol, informed consent form (ICF), case report form (CRF), and clinical study report (CSR) development and review • Proficient in MS Office Suite (Excel, Word, and PowerPoint) • Ability to travel approximately 10% Knowledge and Experience: • Minimum 5+ years of clinical research experience gained with a CRO, biotech or pharmaceutical company working on phase I-IV global clinical trials • 2-3 years leading global clinical trials start up through close out • Experience working with CROs • Experience with metabolic, diabetes, obesity or hypertension trials is preferred Education: • Bachelor's degree is required #LI-CF1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

Lead and manage FSP programs including strategic, operational, financial oversight, customer relationship management, team leadership, and business growth. | Bachelor's degree or equivalent with substantial management experience, deep expertise in FSP leadership or clinical research operations, strong financial and operational management skills, and excellent leadership and communication abilities. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The FSP (Functional Service Provider) General Manager (GM) provides strong leadership and oversees strategic, operational, and financial management of FSP programs for a key customer account. The GM ensures high-quality, cost-effective services, drives business growth, maintains customer relationships, and ensures regulatory compliance. Through leadership, collaboration, and resource optimization, the GM promotes operational excellence, customer satisfaction, and overall success. The GM works closely with the Commercial Account Lead and FSP Program/Functional Leads to drive growth aligned with account strategy and Parexel's priorities. Key Accountabilities Business Operations Act as the primary point of contact for customers at the account level for FSP programs. Ensure the effective and efficient delivery of FSP services. This includes establishing and maintaining quality management systems, functions, performance metrics, implementing process improvements, and ensuring adherence to regulatory requirements and industry standards. Accountable for the financial aspects of the FSP account, including budget planning, resource allocation, cost management, and financial reporting. This involves ensuring profitability (revenue, hiring, and margin targets), monitoring customer contracts, and identifying opportunities for cost savings or revenue generation. Manage the assigned staff to the FSP account, including identifying staffing needs, recruiting, and selecting team members, assigning resources to projects, reviewing invoicing, and optimizing resource utilization. This is done in partnership with the program/functional leads. Collaborate effectively with other functional areas across Parexel to ensure seamless integration and coordination of services for the customer. Advise and provide strategic direction to functional/program leads on overall margin improvement opportunities at account level, including labor cost of the billable FTE and overhead costs. Account Management and Growth Strategy Develop and implement the strategic direction for the FSP account aligned with the overall goals and objectives of the customer account and Parexel. This includes setting operational priorities, identifying opportunities for growth and expansion of roles and services into other functional areas, and establishing performance targets. Define customer specific needs and improvement areas across the FSP account in alignment with their strategic priorities and our capabilities. Ensure the overall satisfaction of the customer. Build, nurture, and maintain key FSP account leadership relationships and communication with customer and internally. Engage FSP customer and internal key stakeholders (inclusive of executive C-Level) in regular governance meetings to review account status and performance. Engage handover from pre-award to post-award as the primary account point of contact for the FSP customer. Maintain extensive knowledge of customer pipelines/ products/ growth strategies. Delivery Oversight & Performance Monitoring Account level oversight for all aspects of FSP operational delivery, including, timely and quality delivery across customer portfolio. Drive operational excellence within the FSP account through best practices, SOPs, and performance metrics. Foster a culture of continuous improvement, define, monitor and report on KPIs, address operational challenges, and support year-over-year improvement in efficiency, quality, risk mitigation and delivery outcomes in collaboration with program/functional leads. Develop & maintain executive summary of operational performance for portfolio of programs across the FSP account. Business Development Assume accountability for identifying and pursuing new FSP business opportunities within existing accounts. Collaborate with the Commercial Account Lead and FSP Solution Consultants to engage customers, negotiate agreements, and drive overall FSP growth in support of account targets. Define the FSP Strategic Account growth strategy, customer engagement level, and objectives aligned with corporate goals and the broader account strategy. Take the lead on repeat business opportunities, including RFP/BDM, and provide subject matter expertise for proposals and bid defense meetings. Line Management Manage employee performance through continuous feedback, goal setting, and performance reviews. Strengthen project delivery and employee satisfaction. Effectively hire and onboard new employees, selecting high-caliber candidates aligned with customer and Parexel's needs. Provide a consistent and positive new hire experience. Sponsor a fit-for-purpose training curriculum and ensure compliance with systems and processes. Provide coaching and mentoring that fosters adaptability, collaboration, and next-line leadership development. Enhance engagement and retention through career development, team engagement, and proactive guidance. Lead team through successful adoption and implementation of organizational changes. Process Improvement Champion process improvement in enterprise-wide strategic initiatives in partnership with other functions and the Operational Excellence and Delivery Office. Skills: Deep understanding of FSP environment at the market and customer level (pipelines/finances/ etc.). Strong understanding of financial management, including budgeting, forecasting, and cost control. Strong leadership skills, including the ability to inspire, motivate, and drive high performance., collaboratively build relationships across disciplines, including the commercial/operations partnership with the customer, demonstrating high emotional intelligence. Solid understanding of project and portfolio level financial reports (Rev/NBA/Margin). Ability to define KPIs, analyze performance, track metrics, and generate accurate reports. Excellent problem-solving skills in a complex environment (internal and external). Proficiency in portfolio/account strategy planning. Ability to set clear performance expectations, establish metrics and goals, conduct regular performance evaluations, and provide ongoing feedback. Leverage analytics for strategy, negotiations, and effective solution implementation by analyzing information, considering alternatives, and implementing effective strategies. Knowledge and Experience: Proven substantial expert project management experience, preferably in healthcare, clinical research, or contract research organization. Deep experience in FSP leadership and management roles, clinical research operations, customer relationship management. Understanding of business development and sales. An operational understanding of quality and compliance management Experience in leading business improvement change efforts. Strong command of written and spoken English language, local language proficiency as required. Education: Bachelor’s degree or equivalent level of education (science or medical related field preferred) or proven substantial management experience. Advanced degree (science, medical, business) desirable. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

Manage and oversee clinical study activities including planning, vendor management, data quality, budget, and regulatory compliance in alignment with global study plans. | Bachelor’s degree with 4+ years clinical trial experience, proficiency in clinical trial systems and MS Office, knowledge of ICH GCP, leadership skills, attention to detail, and budget awareness. | PXL has an exciting opportunity for a Clinical Study Associate Manager (CSAM)! The Clinical Study Associate Manager (CSAM) Service supports the Clinical Study Lead by taking responsibility for areas of clinical trial delivery. The Clinical Study Associate Manager works with the study team internally and externally with vendors such as CROs in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Standard Operating Procedures (SOPs) and ICH/GCP. This Service applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) the balance of direct execution versus oversight of CROs deliverables will vary accordingly. CSAM Duties The Clinical Study Associate Manager perform the following Services: • May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with the global study plans and may contribute to global planning and management of the study • Contributes to risk assessment and helps identify risk mitigation strategies • Supports feasibility assessment to select relevant regions and countries • Oversees and provides input to the development of study specific documentation including but not limited to: case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc. • Reviews site level informed consents and other patient-facing study start-up materials • Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF) Contributes to investigator meeting preparation and execution • Oversees engagement, contracting and management of required vendors for the study • Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation • Provides regular status reports to stakeholders as requested by the Clinical Study Lead • Contributes to development of and oversees implementation of recruitment and retention strategies • Monitors progress for site activation and monitoring visits • Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites • Escalates data flow and data quality issues to Clinical Study Lead • Oversees the execution of the specific clinical study deliverables against planned timelines • Escalates issues related to timelines or budget to Clinical Study Lead • Supports accurate budget management and scope changes • Contributes to clinical project audit and inspection readiness throughout the study lifecycle • Supports internal and external inspection activities and contributes to CAPAs as required • Manages aspects of study close-out activities including but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability • May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring CSAM Requirements • Bachelor’s degree and minimum 4 years of relevant experience • Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS. • Knowledge of ICH GCP and relevant regulatory guidelines/directives • Demonstrated interpersonal & leadership skills • Attention to details for the ability to deliver on specific study activities • Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization • Budget awareness with the ability to participate in various aspects of budget management • Effective communication skills via verbal, written and presentation abilities #LI-KW1 #LI-REMOTE

Support patient recruitment and retention team with administrative tasks, document management, vendor reporting, and clinical systems projects. | 2-5 years clinical research patient recruitment experience, pharmaceutical/biotech/CRO background, bachelor's degree, strong organizational and communication skills. | Job Summary: Parexel is seeking a Patient Recruitment & Retention Specialist to join our dynamic FSP team. This role will be key in supporting the successful implementation of patient recruitment and retention efforts across programs. The primary role is providing general support to the Patient Recruitment & Retention team in delivering and maintaining the team’s objectives. The position offers significant learning and growth opportunities. Key Responsibilities: • Provides general support to the Patient Recruitment & Retention expertise area in delivering and maintaining the team’s objectives • Supports the Patient Recruitment & Retention team with administrative activities including but not limited to updating internal status reports, meeting agendas and minutes, organizing teleconferences, reviewing / filing vendor reports, finance tracking, contracting / SOW development and processing, maintaining internal ROI reporting of team efforts, and supporting internal and external review / approval clinical & MLR process and related documentation tracking • Manages Patient Recruitment material approvals, printing and shipping • Assist with vendor reporting / tracking and ensure all files are up to date with clear history of activities and decisions • Partner with Patient Recruitment Managers and study team members to file documents in the electronic Trial Master File (eTMF) for relevant projects according to applicable study specific requirements and Standard Operating Procedures • Assist with the development and review of content and participate in UAT (User Acceptance Testing), as needed • May contribute to the development and/or review of content for presentations and operations plans for programs • Assist with other clinical systems enhancements/projects and department initiatives as necessary to meet business needs such as development of training materials Skills and Requirements: • Based in East Coast US • 2-5 years of hands on clinical research Patient Recruitment experience. • Direct experience working in a pharmaceutical, biotech, contract research organization, patient recruitment company. • Proficiency in Microsoft Office Suite • Strong organizational, interpersonal, and team-oriented skills. • Excellent verbal, written, communication and time management skills. • Ability to perform several tasks simultaneously to meet deadlines in a dynamic environment. • Ability to be flexible, adapt to change, as well as work as part of a team in a matrix environment under close supervision Education: • Bachelor's degree is required #LI-REMOTE

Write, edit, and manage clinical regulatory documents ensuring compliance with guidelines and timelines while collaborating with cross-functional teams. | 15+ years pharmaceutical medical writing experience with expertise in regulatory documents, ICH guidelines, and ability to work in matrix teams. | Job Summary: The Principal Medical Writer is responsible for writing and overseeing the completion of a broad range of documents in support of company products and projects. This individual will work with the lead and/or program medical writer and independently to develop messages and write, substantively rewrite, and edit documents for clarity and accuracy, ensuring high quality. This individual will help manage project documents and timelines, as well as ensuring that documents comply with International Committee on Harmonization guidelines, SOPs, Good Clinical Practices, and Good Publication Practices. As a study team member, this individual will work with domestic and international colleagues across R&D (as appropriate).to ensure that documents meet the company’s objectives. Key Accountabilities: • Write and edit clinical regulatory documents for clarity, and accuracy according to client standards.. • Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives. • Provide writing support for a wide range of documents, including but not limited to investigator’s brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs. • Ensure that documents comply with International Conference on Harmonization guidelines, SOPs, and Good Clinical Practices. Requirements: • At least 15 years of medical writing experience in the pharmaceutical industry • Ability to write and edit complex material to ensure accuracy and clarity • Experience with a variety of regulatory and clinical documents • Experience in a matrix team environment • Excellent written and oral communication skills and demonstrated problem-solving abilities • Ability to handle multiple projects and short timelines • Ability to work cooperatively with colleagues in a wide range of disciplines • Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents Education: • BA/BS, Advanced degree preferred #LI-LO1 #LI-REMOTE

Write, edit, and oversee clinical regulatory documents ensuring compliance with ICH guidelines and sponsor standards while collaborating with project teams. | At least 4 years pharmaceutical writing experience, knowledge of ICH and CTD guidelines, strong communication skills, ability to manage multiple projects, and BA/BS degree. | Parexel FSP is looking for a Principal Medical Writer! This is a remote role anywhere in the United States or Canada. Job Purpose: The Medical Writer, Medical Writing, is responsible for writing and overseeing the completion of a broad range of documents in support of company products and projects. This individual will work with the lead and/or program medical writer and independently to develop messages and write, substantively rewrite, and edit documents for clarity and accuracy, ensuring high quality. This individual will help manage project documents and timelines, as well as ensuring that documents comply with International Committee on Harmonization guidelines, Sponsor SOPs, Good Clinical Practices, and Good Publication Practices. As a study team member, this individual will work with domestic and international colleagues across R&D (as appropriate).to ensure that documents meet the company’s objectives. Key Accountabilities: Oversight of activities • Write and edit clinical regulatory documents for clarity, and accuracy according to Sponsor standards. • Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives. • Provide writing support for a wide range of documents, including but not limited to investigator’s brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs. • Ensure that documents comply with International Conference on Harmonization guidelines, Sponsor Pharmaceuticals SOPs, and Good Clinical Practices. Collaborative relationships • Collaborates effectively with lead writers and project teams to develop and refine clinical regulatory documents that align with Sponsor standards, ICH guidelines, and Good Clinical Practices, ensuring clear and accurate communication of study data and objectives within submission timelines. Compliance with Parexel standards • Complies with required training curriculum • Completes timesheets accurately as required • Submits expense reports as required • Updates CV as required • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: • At least 4 years of writing experience in the pharmaceutical industry • Experience with a variety of regulatory and clinical documents • Experience in a matrix team environment • Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents Knowledge and Experience: • Ability to write and edit complex material to ensure accuracy and clarity, • Excellent written and oral communication skills and demonstrated problem-solving abilities • Ability to handle multiple projects and short timelines • Ability to work cooperatively with colleagues in a wide range of disciplines Education: • BA/BS or higher #LI-REMOTE

Lead and manage study and country level clinical trial operations including startup, site activation, recruitment strategy, vendor oversight, and risk mitigation. | Bachelor’s degree with 5+ years or Master’s with 3+ years of relevant operational clinical trial experience, preferably scientific or technical background. | The Study Operations Manager I (SOM I) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks. • Serves as leader of the local study team on one or more studies • Provides back up to or assumes the responsibilities of the GSM as needed • Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans) • May manage the study start up process in countries assigned and/or oversee the CRO responsible for these activities as applicable • Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs) • Provides country level input on startup and recruitment milestones during planning • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. • Accountable for resolution of site activation escalations to study teams including offering options for mitigation • Fully responsible and accountable for, as designated by the GSM: • Regional, country, and study level implementation of startup and site activation plans • Regional, country and study level recruitment strategy • Development of study level plans • Communication with the local team and internal stakeholders and CRO as applicable to ensure efficient and timely study delivery of the agreed plans • Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables • Assurance of the follow up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc. Requirements: • Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required • Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required • A scientific or technical degree is preferred #LI-LO1 #LI-REMOTE