{"id":3476302,"url":"https://alion.io/job/takeda-pharmaceutical-lead-clinical-study-manager-4","title":"Lead Clinical Study Manager","company":{"id":5984,"name":"Takeda Pharmaceutical","domain":"takeda.com","url":"https://alion.io/company/takeda","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":89,"open_postings":70,"ghost_share":0,"stale_share":0.4,"repost_share":0.057,"time_to_fill_p50_days":26,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":116000,"max":182270,"currency":"USD","period":"year","gross":null,"usd_annual":182270},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-10-29T18:54:28Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-05T18:09:02Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.\nJob Description\nAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team.\nAt Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. We offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.\nHere, you will be a necessary contributor to our inspiring, bold mission.\nGOALS:\nLead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s):\nOversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.\nOversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.\nThe assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned.\nACCOUNTABILITIES:\nAccountable for planning and operational strategy and execution for assigned clinical trials.Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.\nChallenges study team to ensure operational feasibility, inclusive of patient and site burden\nValidates budget and ensures impacts are adequately addressed.\nParticipates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy.\nChallenges study team to ensure timelines meet the needs of the clinical development plan.\nEnsure new team members and vendors are appropriately onboarded.\n\nDuring Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place.\nProvide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly.\nResponsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs.\nOversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.\nSpecific areas of sponsor oversight include, but are not limited to:Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring\nReview and endorsement of relevant study plans, as applicable\nStudy team meeting management and attendance when necessary; regular review of meeting agendas and minutes\nReview of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study\nDocumented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies\n\nIn partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.\nEnsure studies are “inspection ready” at all time; may be involved in regulatory inspections by preparing for and/or attending the inspections.\nRepresent the Lead Clinical Study Manager role in functional initiatives or working groups. \nHelp with onboarding and mentoring of new or junior CSMs.\nMay assist the program COPL in his/her role, as required\nEDUCATION AND EXPERIENCE:\nBS/BA required preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience.\nAdvanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.\n6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight. Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.\nKnowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.\nDemonstrated excellence in project/program management and matrix leadership.\nExcellent communication skills.\nExcellent teamwork, organizational, interpersonal, and problem-solving skills.\nFluent business English (oral and written).\nTRAVEL REQUIREMENTS:\nRequires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.\nTakeda Compensation and Benefits Summary\nWe understand compensation is an important factoras you consider the next step in your career. We are committed to equitablepay for all employees, and we strive to be more transparent with our pay practices.\nFor Location:\nMassachusetts - VirtualU.S. Base Salary Range:\n$116,000.00 - $182,270.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.\nFor information about our benefits, please click here.\nEEO Statement\nTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.\nLocations\nMassachusetts - VirtualWorker Type\nEmployeeWorker Sub-Type\nRegularTime Type\nFull timeJob Exempt\nYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. 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