Lead Clinical Study Manager (Lead CSM)
Takeda
August 20, 2026
Remote
United States
$116,000 - $182,270 USD yearly
Clinical Research and Development
Lead study operational strategy and planning and oversee execution of clinical studies for assigned clinical program(s) aligned to the Clinical Development Plan.
Responsibilities:
- Oversee study execution in compliance with ICH-GCP, local regulations, and Takeda SOPs; ensure studies are on schedule and on budget.
- Oversee Strategic Partners, CROs, and vendors to meet ICH-GCP obligations and business objectives.
- Provide operational strategy input to protocol synopsis/final protocol and other study documents.
- Challenge feasibility (including patient and site burden), timelines, onboarding of team members/vendors.
- Lead operational strategy development during early partner/CRO engagement; ensure accurate assumptions and robust risk management.
- Oversee/support CROs and ensure rapid issue resolution.
- Own study budget planning/management and external spend accountability; ensure budgets, enrollment, and gating accuracy; communicate status/cost/issues; serve as escalation point.
- Lead vendor selection, budget/contract negotiation, and performance supervision; escalate when warranted.
- Sponsor oversight: monitoring plan/doc approvals, study plan endorsement, meeting management, protocol deviation trend review, issue/risk/decision review with mitigation.
- With data management, pressure-test database timelines and link strategy to database lock/CSR plan.
- Ensure studies are inspection-ready; may support regulatory inspections.
- Represent role in initiatives/working groups; help onboard/mentor new or junior CSMs.
Qualifications:
- BS/BA required (health/life science or technology preferred) or equivalent.
- Advanced degree may supplement.
- 6+ years in pharma and/or CRO; 4+ years clinical study management/oversight; early phase or Phase 2/3; global/international experience; multiple therapeutic areas advantageous.
- Knowledge of global regulatory/compliance (US CFR, EU CTD, ICH-GCP) and local requirements.
- Strong project/program management, matrix leadership, communication, teamwork, organization, interpersonal and problem-solving; fluent business English.
Travel: ~5–20%.
Benefits (U.S. based employees may be eligible): medical/dental/vision, 401(k) match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Location/Work type: Massachusetts (Virtual/Remote).
Responsibilities:
- Oversee study execution in compliance with ICH-GCP, local regulations, and Takeda SOPs; ensure studies are on schedule and on budget.
- Oversee Strategic Partners, CROs, and vendors to meet ICH-GCP obligations and business objectives.
- Provide operational strategy input to protocol synopsis/final protocol and other study documents.
- Challenge feasibility (including patient and site burden), timelines, onboarding of team members/vendors.
- Lead operational strategy development during early partner/CRO engagement; ensure accurate assumptions and robust risk management.
- Oversee/support CROs and ensure rapid issue resolution.
- Own study budget planning/management and external spend accountability; ensure budgets, enrollment, and gating accuracy; communicate status/cost/issues; serve as escalation point.
- Lead vendor selection, budget/contract negotiation, and performance supervision; escalate when warranted.
- Sponsor oversight: monitoring plan/doc approvals, study plan endorsement, meeting management, protocol deviation trend review, issue/risk/decision review with mitigation.
- With data management, pressure-test database timelines and link strategy to database lock/CSR plan.
- Ensure studies are inspection-ready; may support regulatory inspections.
- Represent role in initiatives/working groups; help onboard/mentor new or junior CSMs.
Qualifications:
- BS/BA required (health/life science or technology preferred) or equivalent.
- Advanced degree may supplement.
- 6+ years in pharma and/or CRO; 4+ years clinical study management/oversight; early phase or Phase 2/3; global/international experience; multiple therapeutic areas advantageous.
- Knowledge of global regulatory/compliance (US CFR, EU CTD, ICH-GCP) and local requirements.
- Strong project/program management, matrix leadership, communication, teamwork, organization, interpersonal and problem-solving; fluent business English.
Travel: ~5–20%.
Benefits (U.S. based employees may be eligible): medical/dental/vision, 401(k) match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Location/Work type: Massachusetts (Virtual/Remote).