Lead Clinical Study Manager
About The Position
Takeda is seeking a Lead Clinical Study Manager to lead operational strategy, planning, and execution oversight for clinical studies within assigned clinical programs. The role supports the clinical strategy defined in the Clinical Development Plan and works closely with Clinical Operations Program Leads. Studies may be high-complexity or high-risk, involve multiple indications, oversight committees, interim analyses, multiple vendors, or special assessments. The position may cover more than one study or program. The Lead Clinical Study Manager ensures studies are conducted to quality standards, including ICH GCP, local regulations, and Takeda SOPs, and are delivered on schedule and within budget. The role oversees strategic partners, CROs, and other vendors; provides operational expertise to study documents and planning; manages study budgets and external spend; monitors vendor performance and study risks; and helps ensure inspection readiness. The position is remote and reports to the Clinical Operations Leadership team. Approximately 5–20% travel, including overnight and international travel, is required.
Requirements
- Bachelor’s degree required, preferably in a health-related, life science, or technology-related field, or an equivalent combination of education, training, and experience.
- At least 6 years of experience in the pharmaceutical industry and/or a clinical research organization, including at least 4 years in clinical study management or oversight.
- Experience must include either early-phase clinical studies or Phase 2 and 3 studies, and global/international studies or programs.
- Knowledge of global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP; awareness of local country requirements is also required.
- Demonstrated excellence in project/program management and matrix leadership.
- Excellent communication skills.
- Excellent teamwork, organizational, interpersonal, and problem-solving skills.
- Fluent business English, oral and written.
Nice To Haves
- Experience in more than one therapeutic area is advantageous.
- Advanced degree(s), such as a Master’s or Doctorate, and relevant training or experience may be considered to supplement experience requirements.
Responsibilities
- Lead operational strategy, planning, and execution for assigned clinical studies and trials.
- Oversee study execution in compliance with quality standards, including ICH GCP, local regulations, and Takeda SOPs, and ensure delivery on schedule and within budget.
- Oversee strategic partners, CROs, and other third-party vendors to support Takeda’s obligations and business objectives.
- Provide subject matter expertise and operational input into protocol synopses, final protocols, and other study documents.
- Challenge study teams to assess operational feasibility, patient and site burden, budgets, and timelines against the Clinical Development Plan.
- Participate in country and site feasibility and selection, providing country insights, corporate alignment, and therapeutic expertise.
- Ensure new team members and vendors are appropriately onboarded.
- Lead development of operational strategy with strategic partners and/or CROs during early engagement, including accurate assumptions and robust risk management plans.
- Provide oversight, support, and guidance to strategic partners and CROs to rapidly address and resolve study issues.
- Plan and manage study budgets and external study execution spend; coordinate with Clinical Operations Program Leaders, Global Program Management, and Finance to maintain accurate budgets, enrollment, and gating.
- Communicate study status, costs, and issues to Clinical Operations Program Leads and serve as an escalation point for third-party vendor issues managed by partners or CROs.
- Oversee partner, CRO, and vendor selection, budget and contract negotiation, and performance; escalate issues to governance committees when appropriate.
- Review and approve key monitoring documents and plans, and periodically review monitoring outputs, decisions, and actions.
- Review and endorse relevant study plans, as applicable.
- Manage and attend study team meetings when necessary, and regularly review agendas and minutes.
- Review protocol deviation outcomes and actions to identify trends across sites or the study.
- Document study-level review and monitoring of issues, risks, and decisions, and implement appropriate mitigation strategies.
- Partner with data management to review and pressure-test database timelines and plans and link filing, registration, or data-generation strategy with database lock and CSR tactical plans.
- Ensure studies remain inspection-ready and prepare for and/or attend regulatory inspections as needed.
- Represent the Lead Clinical Study Manager role in functional initiatives or working groups.
- Help onboard and mentor new or junior Clinical Study Managers.
- Assist the program COPL in their role as required.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
