Lead Clinical Study Manager

Lead study operational strategy and planning and oversee execution of clinical studies for assigned clinical program(s), supporting clinical strategy defined in the Clinical Development Plan.

Responsibilities:
- Oversee execution of studies in assigned program(s) in compliance with quality standards (ICH GCP, local regulations, Takeda SOPs), on schedule and on budget.
- Oversee Strategic Partners/CROs and other 3rd-party vendors to meet Takeda obligations (ICH-GCP and 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 documents.
- Challenge study team on operational feasibility (including patient/site burden), budget validation, timelines, onboarding, and feasibility/selection.
- During early engagement, lead development of operational strategy with accurate assumptions and robust risk management.
- Provide oversight/support/guidance to partners/CROs to rapidly resolve study issues.
- Plan/manage study budget and external spend; ensure accurate budgets/enrollment/timing; communicate status/cost/issues; serve as escalation point.
- Oversee partner/CRO/vendor selection, budget/contract negotiation, and performance supervision; escalate issues to governance committees as warranted.
- Sponsor oversight: monitoring plans/documents review/approval; study plan endorsement; study team meeting management; protocol deviation trend review; document review/monitoring of issues/risks/decisions and mitigation.
- In partnership with data management, pressure test database timelines/plans and link strategy to database lock/CSR.
- Ensure studies are “inspection ready” and may support regulatory inspections.
- Represent role in functional initiatives/working groups; onboard/mentor new or junior CSMs; may assist COPL as required.

Qualifications (Education/Experience):
- BS/BA required (preferably health/life sciences/technology) or equivalent combination of education/training/experience.
- Advanced degree(s) may be considered.
- 6+ years pharmaceutical industry and/or CRO experience, including 4+ years clinical study management/oversight; experience in early phase or Phase 2/3; global/international studies/programs; multiple therapeutic areas advantageous.
- Knowledge of global regulatory/compliance requirements (US CFR, EU CTD, ICH GCP) and awareness of local country requirements.

Required/Preferred Skills:
- Demonstrated project/program management and matrix leadership.
- Excellent communication and teamwork/organizational/interpersonal/problem-solving skills.
- Fluent business English (oral and written).

Travel Requirements:
- Approximately 5–20% travel (overnight and international to Takeda sites, strategic partners, and as needed).

Benefits (as stated):
- Eligible for short-term/long-term incentives; medical/dental/vision, 401(k) with match, disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits.
- Up to 80 hours sick time per calendar year; new hires eligible to accrue up to 120 hours paid vacation.

Application instructions:
- By clicking the “Apply” button, application process commences; submitted information processed per Takeda Privacy Notice and Terms of Use.