Lead Clinical Study Manager

Takeda Pharmaceutical Company Limited

Job Overview

Location

Massachusetts - Virtual

Job Type

Full-time

Full Job Description

📋 Description

• Lead operational strategy and execution for assigned clinical studies within a clinical program, ensuring alignment with the Clinical Development Plan and adherence to ICH GCP, local regulations, and Takeda SOPs.
• Oversee high-complexity and/or high-risk clinical trials, including studies with multiple indications, data safety monitoring boards, interim analyses, or coordination of multiple vendors.
• Provide subject matter expertise and operational input into protocol synopsis, final protocol, and other study-related documents to ensure feasibility, patient and site burden reduction, and alignment with program strategy.
• Validate clinical study budgets and ensure financial impacts are accurately assessed and addressed across all study activities.
• Participate in country and site feasibility and selection processes, contributing therapeutic expertise, corporate alignment, and country-specific insights to support study execution.
• Lead the development of Operational Strategy during early engagement with Strategic Partners and CROs, ensuring accurate assumptions and robust risk management plans are established prior to Operational Strategy Review.
• Provide oversight, guidance, and support to Strategic Partners, CROs, and third-party vendors to rapidly resolve study issues and ensure compliance with Takeda’s business objectives and regulatory obligations.
• Manage full lifecycle of vendor selection, contract negotiation, budgeting, and performance supervision for all external partners supporting assigned studies, including escalation of performance issues to governance committees.
• Conduct detailed review and approval of key monitoring documents, plans, outputs, and decisions; monitor trends in protocol deviations across sites to drive quality improvements.
• Review and endorse relevant study plans, attend and manage key study team meetings, and ensure agendas and minutes reflect accurate action items and decisions.
• Collaborate with data management to pressure test database lock timelines and ensure strong linkage between clinical strategy (e.g., filing, registration) and tactical data generation plans for Clinical Study Reports.
• Ensure all clinical studies remain inspection-ready at all times and participate in regulatory inspections by preparing documentation and attending inspection meetings.
• Serve as the primary escalation point for third-party vendor issues managed by Strategic Partners or CROs and communicate study status, budget, enrollment, and gating metrics regularly to Clinical Operations Program Leads.
• Mentor and onboard new or junior Clinical Study Managers, providing operational guidance and leadership development.
• Represent the Lead Clinical Study Manager role in functional initiatives, working groups, and cross-functional teams to advance organizational goals.
• May support the Clinical Operations Program Lead in broader program-level responsibilities as required.
• Manage approximately 5–20% travel, including overnight and international travel to Takeda sites, strategic partners, and therapeutic area meetings.

🎯 Requirements

• BS/BA in health-related, life science, or technology-related field; advanced degree preferred
• 6+ years of experience in pharmaceutical industry or CRO, with 4+ years in clinical study management/oversight
• Proven experience managing early-phase, Phase 2, or Phase 3 clinical studies, including global/international trials
• Demonstrated knowledge of global regulatory requirements (US CFR, EU CTD, ICH GCP) and awareness of local country regulations
• Demonstrated excellence in project/program management and matrix leadership
• Excellent communication, teamwork, organizational, interpersonal, and problem-solving skills

🏖️ Benefits

• Base salary range of $116,000.00 – $182,270.00, determined by experience and location
• Eligibility for short-term and/or long-term incentives
• Medical, dental, and vision insurance coverage
• 401(k) plan with company match
• Up to 120 hours of paid vacation annually and up to 80 hours of sick time per calendar year
• Tuition reimbursement program, paid volunteer time off, and well-being benefits

Skills & Technologies

GCP

Senior

Remote

Degree Required

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Takeda Pharmaceutical Company Limited

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About Takeda Pharmaceutical Company Limited

Global, research-driven biopharmaceutical company headquartered in Japan, tracing its roots to 1781. Focuses on discovering and delivering medicines for oncology, rare diseases, neuroscience, gastroenterology, and plasma-derived therapies. Operates in approximately 80 countries with R&D and manufacturing sites across North America, Europe, and Asia, serving patients in over 80 markets worldwide.

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