Lead Clinical Study Manager

Role Summary

Lead Clinical Study Manager, remotely located, reporting to the Clinical Operations Leadership team. You will lead study operational strategy and planning, oversee execution of clinical studies for assigned programs, and collaborate with Clinical Operations Program Leads to align with the Clinical Development Plan. The role involves managing complex or high-risk studies, overseeing vendors and strategic partners, and ensuring compliance with quality standards, timelines, and budgets.

Responsibilities

• Oversee 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 budget.
• Oversee 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.
• Accountable for planning and operational strategy and execution for 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, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy.
• Challenge study team to ensure timelines meet the needs of the clinical development plan; ensure new team members and vendors are appropriately onboarded.
• During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy and ensure robust risk management plans are in place.
• Provide oversight/support/guidance to Strategic partners/CRO to address and resolve study issues rapidly.
• Responsible for study budget planning and management and accountable for external spend related to study execution; coordinate with Clinical Operations Program Leader(s), Global Program Management, and Finance to maintain accurate budgets, enrollment, and gaiting; communicate status and issues to program leads; escalate to governance as needed.
• Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and supervision of performance; escalate issues to governance when warranted.
• Review and approve key monitoring documents/plans, monitor outputs, and review study plans; manage study team meetings and minutes; review protocol deviations to identify site or study trends; monitor issues, risks, and decisions with mitigation strategies.
• In partnership with data management, review database timelines and plans; ensure linkage between strategy and tactical plan for database lock and CSR.
• Ensure studies are “inspection ready”; participate in regulatory inspections as needed.
• Represent the Lead Clinical Study Manager in functional initiatives or working groups; assist with onboarding and mentoring of new or junior CSMs.
• May assist the program COPL in their role as required.

Qualifications

• BS/BA in a health-related, life science, or technology-related field or equivalent combination of education, training and experience.
• Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience may supplement requirements.
• 6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years in clinical study management/oversight; experience with early phase studies or Phase 2/3 and global/international studies; experience in multiple therapeutic areas is advantageous.
• Knowledge of global regulatory and compliance requirements for clinical research (e.g., US CFR, EU CTD, ICH GCP) and awareness of 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 sites and with strategic partners as needed.

Education

• BS/BA required; advanced degree preferred.