Lead Clinical Study Manager

Lead Clinical Study Manager Join us as the Lead Clinical Study Manager. This role reports to the Clinical Operations Leadership team and will operate remotely, supporting the clinical strategy defined in the Clinical Development Plan. Goals Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting the clinical strategy defined in the Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s), oversee the execution of studies in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Accountabilities Accountable for planning and operational strategy, and execution of assigned clinical trials. Provide subject matter expertise and operational input into protocol synopsis, final protocol and other study‑related documents. Challenge study team to ensure operational feasibility, inclusive of patient and site burden. Validate budget and ensure impacts are adequately addressed. Participate in country and site feasibility/selection process, providing country insights, corporate alignment, and therapeutic expertise. Challenge study team to ensure timelines meet clinical development plan needs. Ensure new team members and vendors are appropriately onboarded. Lead the development of Operational Strategy during early engagement with strategic partners or CROs, ensuring accurate assumptions and robust risk‑management plans. Provide oversight/support/guidance to strategic partners/CROs to resolve study issues rapidly. Manage study budget planning and external spend related to study execution. Communicate study status, cost, and issues to Program Leader(s) and act as escalation point for third‑party vendors managed by strategic partners or CROs. Oversee partner/CRO/vendor selection, budget and contract negotiation, and performance supervision, escalating issues to governance committees when warranted. Review and approve key monitoring documents and plans, and periodic reviews of outputs, decisions, and actions related to monitoring. Endorse study plans as applicable and manage study team meetings, reviewing agendas and minutes. Review protocol deviations, track outcomes/actions, and support trend identification across sites. Monitor risks and decisions at the study level, implementing appropriate mitigation strategies. Collaborate with data management to review database timelines and plans, ensuring alignment between tactical plan and database lock/CSR. Ensure studies are “inspection ready” at all times and prepare for or attend regulatory inspections. Represent the Lead Clinical Study Manager role in functional initiatives or working groups. Help onboard and mentor new or junior CSMs. Education and Experience BS/BA required, preferably in a health‑related, life science, or technology‑related field. Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience may supplement requirements. 6+ years of experience in the pharmaceutical industry and/or clinical research organization, including 4+ years of clinical study management/oversight. Experience with early‑phase, Phase 2, or Phase 3 studies, and global/international programs. Experience across multiple therapeutic areas is advantageous. Knowledge of global regulatory and compliance requirements for clinical research (US CFR, EU CTD, ICH GCP) and local country requirements. Demonstrated excellence in project/program management and matrix leadership. Excellent communication, teamwork, organizational, interpersonal, and problem‑solving skills. Fluent business English (oral and written). Travel Requirements Requires approximately 5–20% travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic‑area‑required destinations. Compensation and Benefits Summary Location: Massachusetts – Virtual U.S. Base Salary Range: $116,000.00 – $182,270.00 (actual offer will depend on qualifications, experience, skills, education, certifications, and location). U.S. based employees may be eligible for short‑term and/or long‑term incentives. Benefits include medical, dental, vision, 401(k) with company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, up to 80 hours of sick time, and up to 120 hours of paid vacation for new hires. EEO Statement Takeda 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, 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