[Remote] Lead Clinical Study Manager

Note: The job is a remote job and is open to candidates in USA. Takeda is a patient-focused, innovation-driven pharmaceutical company seeking a Lead Clinical Study Manager to oversee clinical studies and operational strategy. The role involves ensuring compliance with quality standards, managing budgets, and providing oversight to strategic partners and vendors in the execution of high-complexity clinical trials.ResponsibilitiesLead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development PlanOversee 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 budgetOversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectivesAccountable for planning and operational strategy and execution for assigned clinical trialsProvides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documentsChallenges study team to ensure operational feasibility, inclusive of patient and site burdenValidates budget and ensures impacts are adequately addressedParticipates 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 strategyChallenges study team to ensure timelines meet the needs of the clinical development planEnsure new team members and vendors are appropriately onboardedDuring 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 placeProvide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidlyResponsible for study budget planning and management and accountable for external spend related to study executionWorks 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 CROsOversee 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 warrantedSpecific 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 monitoringReview and endorsement of relevant study plans, as applicableStudy team meeting management and attendance when necessary; regular review of meeting agendas and minutesReview of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the studyDocumented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategiesIn 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 CSREnsure studies are “inspection ready” at all time; may be involved in regulatory inspections by preparing for and/or attending the inspectionsRepresent the Lead Clinical Study Manager role in functional initiatives or working groupsHelp with onboarding and mentoring of new or junior CSMsMay assist the program COPL in his/her role, as requiredSkillsBS/BA required preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experienceAdvanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship, internships, etc.) may be considered to supplement experience requirements6+ 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 advantageousKnowledge 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 requiredDemonstrated excellence in project/program management and matrix leadershipExcellent communication skillsExcellent teamwork, organizational, interpersonal, and problem-solving skillsFluent business English (oral and written)BenefitsU.S. based employees may be eligible for short-term and/ or long-term incentives.U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.Company OverviewTakeda is a biopharmaceutical company that researches and develops pharmaceutical drugs. It was founded in 1781, and is headquartered in Tokyo, Tokyo, JPN, with a workforce of 10001+ employees. Its website is http://www.takeda.com.Company H1B SponsorshipTakeda has a track record of offering H1B sponsorships, with 11 in 2026, 44 in 2025, 39 in 2024, 38 in 2023, 34 in 2022, 44 in 2021, 18 in 2020. Please note that this does not guarantee sponsorship for this specific role.