Parexel

Lead TMF strategy, governance, and inspection readiness across clinical programs ensuring regulatory compliance. | 8+ years biotech/pharma clinical operations experience with strong knowledge of ICH-GCP and TMF best practices. | Parexel FSP is seeking a strategic and highly motivated Associate Director, Trial Master File (TMF)/ Clinical Operations to provide enterprise-level oversight and governance of Trial Master File (TMF) activities across clinical programs, including pivotal studies supporting BLA submissions. This role is responsible for ensuring the TMF is maintained in a continuous state of inspection readiness and is compliant with ICH E6(R3), FDA regulations (21 CFR Parts 11 and 312), BIMO expectations, and the DIA TMF Reference Model. The Associate Director will lead TMF quality, remediation, and CRO oversight initiatives to ensure completeness, accuracy, and regulatory defensibility of TMF documentation, while driving sustainable processes and cross-functional accountability aligned with inspection and submission timeline Responsibilities: • Lead TMF strategy, build, maintenance and governance across assigned clinical programs, ensuring alignment with BLA submission timelines and Health Authority inspection expectations while serving as the primary TMF point of contact. • Establish and maintain TMF governance standards, quality metrics, and executive visibility into TMF health, risk, and inspection readiness. • Define and enforce filing standards, naming conventions, metadata governance, and artifact classification aligned with the DIA TMF Reference Model and ICH-GCP requirements. • Develop and oversee TMF quality reporting, dashboards, and outputs to support proactive quality oversight and decision-making. • Create and support study teams in developing and executing Study TMF Filing Plans and Expected Document Lists (EDLs). • Implement and oversee a risk-based TMF Quality Control (QC) framework, including ongoing health checks, pre-submission, and pre-inspection reviews to ensure completeness, accuracy, and audit trail defensibility. • Maintain TMFs in a continuous state of inspection readiness and lead preparation for Health Authority inspections (e.g., FDA BIMO, Pre-Approval Inspections), including mock inspections and inspection narrative development. • Lead TMF gap assessments and structured remediation initiatives, prioritizing BLA-enabling programs and key regulatory milestones. • Author, maintain, and implement TMF-related SOPs, work instructions, training materials, and knowledge resources. • Provide strategic oversight of CRO and vendor TMF performance, including SLA monitoring, governance reviews, quality trend analysis, and TMF migration oversight. • Drive cross-functional accountability for TMF compliance, coach study teams and vendors on regulatory expectations, and serve as the TMF lead and escalation point during inspections Qualifications: • Bachelor’s degree in a related field with 8+ years of experience in biotech/pharma within Clinical Operations, TMF, and/or GCP Quality • Strong knowledge of ICH-GCP, regulatory requirements, and cross-functional clinical trial processes • Demonstrated experience supporting Health Authority inspections (e.g., FDA, EMA) preferred • Working knowledge of the DIA TMF Reference Model and TMF best practices • Experience with Veeva eTMF/Clinical systems and electronic document management systems strongly preferred • Solid understanding of TMF compliance, auditing processes, and inspection readiness expectations • Familiarity with regulatory inspections related to NDA/BLA/MAA submissions preferred • Excellent interpersonal and influencing skills in a cross-functional, matrixed environment • Proven ability to manage complex priorities, drive continuous improvement, and work independently with a proactive mindset • Strong organizational, analytical, and problem-solving skills with the ability to meet tight timelines #LI-REMOTE

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

Manage and oversee clinical trial study operations at country or regional level including study startup, vendor coordination, risk mitigation, and compliance. | 3-7 years clinical trial study management experience, Bachelor’s or Master’s degree preferably scientific or technical, knowledge of GCP and clinical operations, ability to travel and work outside core hours. | 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 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 studies of limited complexity (a small number of countries/sites) or manages portions of a larger study (such as recruitment and retention). Key Accountabilities: Study Management Oversight Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) 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 [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs) Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM 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 May be responsible and accountable for, as designated by the GSM: Regional, country and study level recruitment strategy Support of the development of study level plans Communication with the local team and internal stakeholders and pCRO 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 o 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. Study Management Operations Acts as the point of contact for all study level questions for the local study team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles and teams May lead operational effectiveness initiatives at country or regional level Utilizes roles in country such as Lead SCP, and expert roles such as Contracts Leads and SAPs, to provide the global teams with local intelligence and operational nuances to be considered Provides input on country level per subject costs, local vendor costs, and other fees where applicable Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan and Study Monitoring Plan, and ensures Trial Master File (TMF) completeness and oversight of all relevant compliance activities for allocated studies Supports implementation of client’s site technology experience systems Supports implementation of new tools and technologies (e.g., eConsent, eISF, remote source access, remote source data verification/review (SDV/SDR), iConnect, implementation of protocol required decentralized trial options) 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 Expertise in the use of study and site dashboards and reporting tools Detail oriented and possesses technical expertise Ability to manage moderately complex processes Risk identification and mitigation, strategic planning, and critical path analysis skills Analytical and problem solving skills Ability to adapt to changing technologies and processes, work independently and exercise own judgement Supportive of an environment where innovation is standard, including developing ideas and taking appropriate risks to advance innovative processes Effective verbal and written communication skills in relating to colleagues and associates, both inside and outside of the organization Ability to operate in a matrix environment Fluency in written and spoken English required Ability to work outside of core business hours, as required, to support global trials or initiatives Ability to travel, as required, including Investigator Meetings, vendor kick off and re-set meetings, and client internal global or department level meetings Knowledge and Experience: 3-5 years clinical trial study management experience required Comprehensive knowledge of own discipline with good knowledge of other disciplines to ensure that the study can meet its goals and to serve as a resource for others Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility Demonstrated clinical research experience and/or study management/startup project manager experience Demonstrated experience in managing country level operational activities and/or vendors • Experience in study and quality management Knowledge of clinical trial methodology Experience working in a matrix management environment Relevant operational clinical trial experience Education: Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial operations experience required OR Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required A scientific or technical degree is 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 Start Up Project Manager is responsible for defining, developing, and delivering the global start-up project strategy by partnering with various roles. They oversee site activations and ensure that all investigative sites are activated and ready to enroll participants. | Candidates should have extensive global start-up clinical trial management experience and a comprehensive working knowledge of Good Clinical Practices. A scientific or technical degree is preferred, with 5 years of relevant experience 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 Start Up Project Manager is responsible for defining, developing and delivering the global start up project strategy by partnering with roles across GSSO, CD&O, Global Regulatory Submissions and others as required. The SUPM will be assigned to one or more interventional studies in one or more therapy areas such as oncology, vaccines, internal medicine, rare disease or inflammation and immunology. The responsibility of the SUPM typically ends when all investigative sites are activated and ready to enroll participants, however this can extend further into the participant recruitment period to specifically deliver the implementation of protocol amendments across active sites for selected studies. The SUPM will have a comprehensive knowledge of managing and coordinating study start up activities globally. The SUPM will typically take full responsibility for small to medium size studies located in a single country or region, or for selected countries or region(s) within a larger global study where another SUPM is responsible for the site activations of the entire study. The SUPM is the leader of the start up sub team for the study, region(s) or countries assigned. Project Management: Partner with country/site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities to form a robust start-up strategy and site activation plan Continually assess current and future workload (with other SUPMs on study if applicable) in order to proactively anticipate, problem solve and request appropriate changes to the SUPM team assigned to deliver site activations to plan As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership). Start up meetings use the ongoing risk assessment of site activation delivery to form a focused agenda according to risk level, the overall goal is the delivery of major study milestones to plan (e.g. first subject first visit) as well as the overall delivery of major site activations to plan (25%, 50% and 90% of planned site activations) The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study, they will do so while considering the relative priority of their study compared to all concurrent studies in start up that country level start up roles are working on Plan Delivery: Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system, either directly responsible for setting and maintaining timelines (study level) or oversight of other roles setting and maintaining timelines (country and site level) Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system which build the overall targets for site activation over time In conjunction with study management roles is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies Expertly integrate the requirements of a protocol amendment(s) to deliver site activations to plan, on request manage the green lighting of sites to implement a protocol amendment after sites are activated for assigned study, region(s) or countries The SUPM is responsible for delivering site activations to plan, for the SUPM I this can be for all sites for an entire study or a portion of sites in specific countries in one or more regions Responsible for the completeness and quality of site activation timeline plans for every site from investigator initiation package sent for first site in study, to site activation complete for last site in study. Will work with and drive all timeline plan owners (e.g. country start up roles) to actively manage the site activation timeline plans for their assigned sites. The SUPM will have a detailed understanding of the timeline for every site: Risk Mitigation: Coordinates across the study team and extended partners to deliver site activations to plan for the study or regions/countries assigned, assesses the ongoing site activation readiness status as well as proactively identifying and mitigating risks Act as a key point of escalations for site activation related issues raised by country level start up roles, seeking to firstly resolve issues directly or triage appropriately to other SUPMs on the study or the study management team, will always follow through to resolution Skills: Country or Regional start up exposure/experience in the countries under responsibility across at least two major therapeutic areas Technical expertise in use of software (off the shelf and custom) for the management of clinical studies with prowess in using reporting systems (dashboards and associated basic data analysis) to comprehend and communicate status Ability to use basic generative artificial intelligence techniques in daily work Will use standard risk management methodology to identify and mitigate key risks Fluency in English is required Knowledge and Experience: Extensive global start up clinical trial/study management experience Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations Extensive knowledge of clinical trial methodology Demonstrated start up experience Demonstrated project management experience Education: A scientific or technical degree is preferred Must have a BS/BA – 5 years relevant experience MS/PhD – 3 years relevant experience 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 clinical study site and country feasibility strategy, provide data-driven enrollment and site selection plans, and support continuous process improvements for clinical trial delivery. | 7+ years relevant experience in clinical research or drug development, knowledge of global site feasibility and clinical operations, strong communication and strategic planning skills. | The Feasibility Strategic Analytics Lead (FSAL) (Sr. Manager) will be responsible for partnering with Clinical Study Team Lead (CSTL), Participant Recruitment (PR), GSSO roles, and Clinical Leads to enable the predictable delivery of the portfolio by providing rapid, accurate and robust assessments of program and protocol feasibility, recruitment enrollment assumptions, and site strategy plans. This individual will provide the study team with robust scenario planning to inform and finalize an optimized country, site and enrollment study enrollment plan by leveraging data driven estimates, benchmarking assumptions, competitive intelligence, indication level knowledge, internal and external data sources, and the site predictability engine. These individual drives country and site selection for PTA for the study plan and leads the delivery of sites endorsed for Pre Trial Assessment for the study through the planning of the optimal country and site footprint taking into consideration site classification strategies. At the Sr. Manager level, the FSAL provides the study team recommendations on country and site selection, develops ideas to bridge the gap between evidence driven assumptions and recruitment goals and has advanced knowledge in the field of country and site strategy and feasibility. They bring analytical expertise and innovative approaches to streamline feasibility assessments, ensuring decisions are data-driven and aligned with company goals. This position requires a deep understanding of the clinical trial landscape and the ability to provide strategic input into the design and execution of feasibility studies. By identifying opportunities for process improvement and influencing cross functional teams, this role contributes to the continuous enhancement of the feasibility process, supporting the delivery of high-quality, efficient clinical trials. JOB RESPONSIBILITIES • The Feasibility Strategy & Analytics Lead (FSAL) is single point of contact for the study team in the build of evidence driven study assumptions to provide a country and site strategy that includes a list of proposed countries and sites to be targeted during site feasibility/selection, enrollment scenarios, and protocol optimization strategies. FSALs will continue to support study team enrollment to assess future changes to that strategy (e.g. plan adjustments or rebaseline) through the completion of participant recruitment • Implementing processes related to country & site intelligence and provide continuity by connecting and documenting changes throughout the lifecycle (from early estimates, early feasibility, detailed assumptions, detailed feasibility, to participant recruitment, study start-up planning and last subject first visit) • Provides early feasibility (before core protocol elements are available) by providing initial enrollment timelines, potential country footprint, primary intelligence gathering (benchmark studies, competitive landscape, treatment approvals etc), and key enrollment assumptions to inform initial high level Op Plan assumptions • Introduces opportunities for protocol optimization by leveraging real world data, investigator insights, patient insights, protocol simulations, and coordinates with relevant functions to incorporate these insights in study assumptions. • As protocol elements evolve to final protocol and start up stages, the Feasibility Strategy & Analytics Lead (FSAL) will continue to evolve detail on country footprint, enrollment assumptions, and appropriate site classification strategy • Support the build of the investigator database, collection of information supporting the definition of the ideal site for a study, identification of suitable sites for a study, and coordinate global efforts for site intelligence • Author and maintain oversight of both Country and Site Feasibility outreach and engagement, lead response reviews with appropriate study team members, and provide strategic input into team decision making • Analyze results of outreach and evidence to build the recommended country and site strategy • Provide summary site analytics as the volume of sites is progressed through evaluation stages to Pre Trial Assessment (PTA) to ultimate Site Selection. Analytics include modeling volume of patients (by site classification); ability of site mix to achieve clinical trial diversity goals; competition, site overlap and other key parameters identified as performance drivers by study team • Leveraging the totality of data available (internal, external and regional intelligence), provide strategic scenarios based upon team input and request, to team on options and levers to optimize site footprint and enrollment timelines • Partners with CD&O teams, and RU/BU partners to improve overall study start up and recruitment cycle time metrics. • Operational responsibility for delivering to agreed set of KPIs for assigned protocols. • Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity through uptake of innovative strategies • Influences alignment of business strategies that promote the widespread implementation of suitable clinical trial technologies • Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitates effective portfolio delivery At an above study level, focused on: • Establish and maintain a portfolio aligned “living library” of knowledge that is continuously updated as evidence and intelligence evolves over time • Provide re-occurring assessment of comparator studies and key trial metrics such as country experience, site access, randomization rates, retention rates and protocol insights such as commonly used trial inclusion / exclusion criteria, # of endpoints etc. • Analysis of program / indication level real world data, standard of care, recruitment rates, and evidence to profile geographic disease prevalence rates and insights on appropriate care settings for specific patient populations that can be translated into future site requirements for individual clinical trials • Partner with the OARS/GSSO teams to develop intelligence on preferred sites for the disease indication, in alignment with site classification strategy (strategic sites, high volume sites, diverse population sites etc.). • Continually evaluate overlapping sites within indication and make above study recommendations when additional (naïve) sites need to be factored into site selection; influence stakeholder decision making and uptake of naïve sites • Analyze Decentralized Clinical Trial (DCT) applications to fully understand DCT options as they relate to countries and sites (uptake, performance etc). Inventory of historically used DCT strategies and impact within disease indication (e.g., decentralized trials). Recommendation of category appropriate strategies, influence stakeholder decision making and uptake of DCT strategies where applicable within Category • Evaluation of assets within early-stage portfolio to begin preparations of Knowledge Library in advance of formal trial feasibility engagement • Partnership with Platform Analytics Lines within OARS to outline custom internal/external data needs to support emerging disease indications QUALIFICATIONS / SKILLS • BS / RN / MS & 7 years relevant experience  PhD / MD and 3 years relevant experience • Knowledge of Drug development, a thorough understanding of the processes associated with global country and site feasibility, clinical study start-up and business operations • Experience in clinical research, including clinical trial conduct, knowledge of GCP and a good understanding of the processes associated with study/project management, monitoring, clinical and regulatory operations  History of success in a customer service role with demonstration of meeting customer expectations. • Strong verbal and written communication skills. Effective presentation and facilitation skills. • Well-developed strategic planning, observation, analytical operational execution and problem-solving skills • Strong business consultancy skills, including ability to persuade, negotiate, and moderate conflict • Ability to multitask under tight deadlines on several projects with specific and unique requirements, while providing attention to detail and high-quality work. • Able to synthesize key messages pulling across multiple data sets PREFERRED QUALIFICATIONS • Experience in operations involving multinational clinical trials is preferred. • Prior experience in global country and site feasibility preferred • Able to make complex decisions that require assessing and choosing amongst multiple options, amidst competing priorities, and in ambiguous situations, to timelines and with available resources. • Conversant with the long-term strategy of the business and is able to leverage this in order to prioritize activities and answer key business questions. #LI-LG4 #LI-REMOTE