Lead Clinical Study Manager

Lead study operational strategy and plan clinical studies for assigned clinical program(s) in support of the Clinical Development Plan.

Responsibilities
- Oversee study execution for 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 ICH-GCP and business objectives.
- Provide subject matter expertise and operational input into protocol synopsis, final protocol, and other study documents.
- Challenge teams to ensure operational feasibility (including patient/site burden), feasibility/selection, and timelines aligned to the development plan.
- Validate and manage study budget; ensure impacts are addressed.
- Lead/prepare operational strategy during early engagement and support operational strategy review (assumptions and risk management).
- Provide oversight/guidance to partners/CROs to resolve study issues rapidly.
- Plan/manage study budgets and external spend; ensure accurate budgets, enrollment, and gating; communicate status/cost/issues; serve as escalation point.
- Oversee vendor selection, budget/contract negotiation, and supervision of partner performance; escalate issues to governance as needed.
- Sponsor oversight: monitoring plans/documents review; endorse study plans; manage/attend study team meetings; review protocol deviations/trends; monitor issues/risks/decisions and mitigation.
- Partner with data management to pressure test database timelines/plans; ensure linkage to database lock and CSR.
- Ensure studies are inspection ready; may support regulatory inspections.
- Represent role in initiatives/working groups; onboard/mentor new or junior CSMs; may assist program COPL.

Qualifications (Required/Preferred)
- BS/BA required (preferably health/life sciences or technology-related) or equivalent combination of education/training/experience.
- Advanced degree (Master/Doctorate) may supplement requirements.
- 6+ years pharmaceutical industry and/or CRO experience, including 4+ years clinical study management/oversight; experience with early phase or Phase 2/3, and global/international studies/programs (more than one therapeutic area advantageous).
- Knowledge of global regulatory/compliance requirements (US CFR, EU CTD, ICH GCP) and awareness of local country requirements.
- Demonstrated excellence in project/program management and matrix leadership.
- Excellent communication skills; strong teamwork/organizational/interpersonal/problem-solving skills; fluent business English (oral/written).

Skills
- Operational strategy development, risk management, vendor/CRO oversight, budget management, sponsor oversight, and inspection readiness.

Travel
- Approximately 5–20% travel.

Benefits/Compensation
- U.S. base salary range (Massachusetts - Virtual): $111,800.00–$175,670.00.
- May be eligible for short-term/long-term incentives.
- May be eligible for medical, dental, vision insurance, 401(k) match, short-term/long-term disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, up to 80 hours/year sick time, and up to 120 hours paid vacation for new hires.

Application instructions
- None stated beyond the “Apply” button notice.