Clinical Study Manager

Job Overview Clinical Study Manager (remote) reporting to the Clinical Operations Leadership team. This role leads the operational strategy and planning and oversees execution of clinical studies for assigned clinical programs. The role supports clinical development plans and ensures adherence to quality standards, schedules, budgets, and partnership obligations. Responsibilities Lead study operational strategy and planning and oversee the execution of clinical studies for assigned clinical programs, supporting the clinical strategy defined in the Clinical Development Plan. Collaborate with Clinical Operations Program Leads to oversee execution in compliance with ICH GCP, local regulations, and Takeda SOPs, ensuring studies stay on schedule and on budget. Oversee Strategic Partners and/or CROs and other third‑party vendors to meet Takeda’s obligations under ICH‑GCP and business objectives for studies of low to medium complexity. Provide subject‑matter expertise and operational input into protocol synopsis, final protocol, and other study‑related documents. Challenge the study team to ensure operational feasibility, including patient and site burden. Validate budgets and ensure impacts are adequately addressed. Participate in country and site feasibility/selection, providing country insights, corporate alignment, and therapeutic expertise to align the study execution plan with program strategy. Ensure study timelines meet the needs of the clinical development plan. Ensure new team members and vendors are appropriately onboarded. During early engagement with Strategic Partners and/or CROs, lead the development of the operational strategy, ensuring accurate assumptions and robust risk‑management plans. Provide oversight, support, and guidance to partners/CROs so study issues are addressed and resolved rapidly. Plan and manage study budgets, being accountable for external spend, and work closely with Finance and Program Leaders to keep budgets, enrollment, and gating accurate. Lead the selection, budgeting, contract negotiation, and supervision of Strategic Partners/CROs and other vendors, escalating issues to governance committees when warranted. Specific sponsor oversight, including but not limited to: Review and approval of key monitoring documents/plans, and periodic review of outputs and actions. Review and endorsement of relevant study plans. Manage study team meetings, reviewing agendas and minutes. Review outcomes/actions related to protocol deviations to identify site or study trends. Document review and monitoring of issues, risks, and decisions at the study level, implementing mitigation strategies. In partnership with data management, review and pressure-test database timelines and plans, ensuring linkage between the strategy and tactical plans for database lock and CSR. Ensure studies are “inspection ready” at all times and, if needed, support regulatory inspections through preparation and attendance. Qualifications BS/BA required, preferably in health‑related, life‑science, technology‑related fields or an equivalent combination of education, training, and experience. Advanced degree(s) (e.g., Master’s or Doctorate) and relevant training or experience may be considered. 5+ years of experience in the pharmaceutical industry and/or clinical research organization, including 3+ years in clinical study management/oversight, and significant support experience (e.g., clinical trial assistant/associate or lead CRA). Experience with early‑phase, Phase2, and Phase3 studies, as well as global or international studies or programs. Experience across multiple therapeutic areas is advantageous. Knowledge of global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICHGCP. Awareness of local country requirements. Demonstrated project/program management and matrix leadership experience. Strong communication, teamwork, organizational, interpersonal, and problem‑solving skills. Fluent business English (oral and written). Compensation and Benefits Location: Massachusetts (virtual). U.S. base salary range: $103,500.00 – $162,690.00. Salary range reflects the anticipated range for this position and may vary based on qualifications, experience, and other factors. U.S. employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, a 401(k) plan with company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well‑being benefits. U.S. employees are eligible to accrue up to 80 hours of sick time and up to 120 hours of paid vacation. EEO Statement Takeda is proud of 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. #J-18808-Ljbffr