Lead Clinical Study Manager

Global Development Organization (GDO) – Global Clinical Development Operations (GCDO) / Study Management. Remote role.

About the role

Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in the Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s), lead the cross-functional study execution team (SET) for assigned clinical studies to meet study objectives in compliance with quality standards (including ICH GCP, local regulations, and Takeda SOPs), on schedule, and on budget. Oversee Strategic Partners, CROs, and other third-party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. May collaborate with one or more Clinical Study Managers or other study management colleagues. The assigned clinical studies may be of high complexity and/or high priority, involving more than one study and/or program.

Responsibilities

• Accountable for planning, operational strategy, and execution for assigned clinical trials, providing subject-matter expertise and operational input into protocol synopsis, final protocol, and other study-related documents.
• Challenge the study execution team (SET) to ensure operational feasibility, including patient and site burden.
• Validate budget and ensure impacts are adequately addressed; participate in country and site feasibility/selection with a focus on country insights, corporate alignment, and therapeutic expertise.
• Ensure timelines align with the clinical development plan; oversee onboarding of new team members and vendors.
• Lead development of the Operational Strategy during Early Engagement with Strategic Partners/CROs, ensuring accurate assumptions and robust risk management plans.
• Provide oversight, support, and guidance to Strategic Partners/CROs to identify and mitigate study risks, and resolve issues rapidly.
• Manage study budget planning and external spend; collaborate with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure accurate budget updates and financial system tracking.
• Communicate study status, costs, and issues to Clinical Operations Program Lead(s); serve as escalation point for third-party vendors.
• Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and performance supervision, including escalation to governance committees when warranted.
• Review and approve key monitoring documents/plans; endorse relevant study plans; review protocol deviations to identify trends across sites/studies.
• Monitor and document study-level issues, risks, and decisions, implementing mitigation strategies as needed.
• Partner with data management, statistics, and regulatory teams to align database timelines and plans with study data generation, database lock (DBL), and clinical study report (CSR) delivery in accordance with filing and registration strategies.
• Ensure studies are “inspection ready” at all times; participate in regulatory agency inspections as a subject-matter expert on trial conduct.
• Represent the Clinical Study Manager role in functional initiatives or working groups.
• Assist with onboarding and mentoring study management team members; may support the Clinical Operations Program Lead as required.

Requirements

• BS/BA required, preferably in a health-related, life science, or technology-related field, or equivalent combination of education, training, and experience.
• 6+ years’ experience in the pharmaceutical industry and/or clinical research organization, including 4+ years in clinical study management/oversight.
• Experience with early-phase clinical studies or Phase 2 and 3 studies, and global/international studies or programs; experience in multiple therapeutic areas is advantageous.
• Advanced degree(s) (e.g., Master’s or Doctorate) and relevant training/experience (e.g., fellowships, internships) may supplement experience requirements.
• Knowledge of global regulatory and compliance requirements for clinical research, including US CFR, EU CTR, and ICH GCP; awareness of local country requirements.
• Demonstrated success in project/program management and matrix leadership.
• Excellent communication, teamwork, organizational, interpersonal, and problem-solving skills.
• Fluent business English (oral and written).
• Approximately 5–20% travel, including overnight and international travel to Takeda sites, strategic partners, and therapeutic area-related destinations.

Pay

For location: Massachusetts – Virtual U.S. Base Salary Range: $116,000.00 – $182,270.00. The actual base salary offered may depend on qualifications, experience, skills, education, location, and other factors. U.S.-based employees may be eligible for short-term and/or long-term incentives.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation per year.