{"id":2462741,"url":"https://alion.io/job/takeda-pharmaceutical-lead-clinical-study-manager-3","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":86,"open_postings":38,"ghost_share":0,"stale_share":0.553,"repost_share":0,"time_to_fill_p50_days":24,"computed_at":"2026-10-21T05:46:15Z"}},"role":"Customer Success","role_family":"Customer Success","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":"GCP","optional":false}],"status":"live","first_seen_at":"2026-10-13T17:43:16Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-22T02:05:17Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"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\nJob Description\nJob Title:\nLead Clinical Study Manager (Lead CSM)\nBU/Organization:\nGlobal Development Organization (GDO)\nDepartment/\nFunction:\nGlobal Clinical Development Operations (GCDO) /\nStudy Management\nLocation and Flex Work Arrangement:\nRemote\nJob Code/\nJob Profile:\nnot required for contractor\n60099263\nSupervisor:\nAssociate Director/Director, Study Management\nCompensation Grade Profile:\nnot required for contractor\n150\nObjective / Purpose:\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.\nIn close collaboration with Clinical Operations Program Lead(s):\nLead the cross functional study execution team (SET) for assigned clinical studies program(s) to meet study objectives 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.\nMay collaborate with one, or more, CSMs, or other study management colleagues\nThe assigned clinical studies may be of high-level of complexity and/or high priority. 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.\nProvides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.\nChallenges study execution team (SET) 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 execution team (SET) to ensure timelines meet the needs of the clinical development plan.\nEnsure new team members and vendors are appropriately onboarded.\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 risks are identified and mitigated, and issues are addressed and resolved rapidly. \nResponsible for study budget planning and management and accountable for external spend related to end-to-end study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, external spend, enrollment, and ensure timely updates of budget and financial systems are accurate. Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Takeda and/or Strategic Partner and/or other CROs.\nCommunicates study status, cost and issues to Clinical Operations Program Lead(s); serves as escalation point for third party vendors managed by Takeda, 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\n Review and endorsement of relevant study plans, as applicable\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, statistics and regulatory teams to review and provide input on all database timelines and plans, ensuring strong alignment between study data generation, database lock (DBL), and clinical study report (CSR) delivery; in accordance with overarching filing and registration strategies.\nEnsure studies are “inspection ready” at all time; in the case of a regulatory agency inspection the Lead CSM will be involved in preparing for and/or attending the inspection as a subject matter expert on the conduct of the trial. \nRepresent the Clinical Study Manager role in functional initiatives or working groups. \nHelp with onboarding and mentoring of study management teams members.\nMay assist the program COPL in his/her role, as required.\nEducation & Competencies (Technical and Behavioral):\nBS/BA required, preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience\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.\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. \nKnowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTR, and ICH GCP. Awareness of local country requirements is also required.\nDemonstrated successful experience in project/program management and matrix leadership\nGood communication skills\nExcellent teamwork, organizational, interpersonal, and problem-solving skills\nFluent business English (oral and written)\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:\nUSA - MA - 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\nUSA - MA - 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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