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; oversee execution of clinical studies for assigned clinical program(s), supporting 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 and/or CROs and other 3rd-party vendors.
- Provide operational input into protocol documents; ensure operational feasibility including patient and site burden.
- Validate budgets and ensure impacts are addressed.
- Participate in country/site feasibility and selection; provide country insights and therapeutic expertise.
- Ensure timelines meet clinical development plan needs.
- Lead operational strategy development during early partner engagement; ensure robust risk management.
- Provide oversight/support to partners/CROs to resolve issues rapidly.
- Lead study budget planning/management and external spend; communicate status/cost/issues; serve as vendor escalation point.
- Oversee partner/CRO/vendor selection, budgeting, contract negotiation, and performance supervision; escalate issues to governance.
- Sponsor oversight: key monitoring document review/approval; endorsement of study plans; study meeting management; review of protocol deviations trends; review/monitor risks and mitigation.
- Review/pressure test database timelines; ensure linkage to database lock/CSR plan.
- Ensure “inspection ready” studies; prepare for/attend inspections.
- Represent role in initiatives/working groups; onboard/mentor new or junior CSMs.
Qualifications & skills:
- BS/BA required (health/life science or technology preferred).
- 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 clinical regulatory/compliance (US CFR, EU CTD, ICH GCP) and awareness of local requirements.
- Strong project/program management, matrix leadership, communication, teamwork, organization, interpersonal and problem-solving skills.
- Fluent business English.
Travel: ~5–20%.
Benefits (if applicable): Eligible for medical/dental/vision, 401(k) with match, short/long-term disability, 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.
Application instructions: Apply via the “Apply” button (acknowledging privacy notice and terms of use).
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 and/or CROs and other 3rd-party vendors.
- Provide operational input into protocol documents; ensure operational feasibility including patient and site burden.
- Validate budgets and ensure impacts are addressed.
- Participate in country/site feasibility and selection; provide country insights and therapeutic expertise.
- Ensure timelines meet clinical development plan needs.
- Lead operational strategy development during early partner engagement; ensure robust risk management.
- Provide oversight/support to partners/CROs to resolve issues rapidly.
- Lead study budget planning/management and external spend; communicate status/cost/issues; serve as vendor escalation point.
- Oversee partner/CRO/vendor selection, budgeting, contract negotiation, and performance supervision; escalate issues to governance.
- Sponsor oversight: key monitoring document review/approval; endorsement of study plans; study meeting management; review of protocol deviations trends; review/monitor risks and mitigation.
- Review/pressure test database timelines; ensure linkage to database lock/CSR plan.
- Ensure “inspection ready” studies; prepare for/attend inspections.
- Represent role in initiatives/working groups; onboard/mentor new or junior CSMs.
Qualifications & skills:
- BS/BA required (health/life science or technology preferred).
- 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 clinical regulatory/compliance (US CFR, EU CTD, ICH GCP) and awareness of local requirements.
- Strong project/program management, matrix leadership, communication, teamwork, organization, interpersonal and problem-solving skills.
- Fluent business English.
Travel: ~5–20%.
Benefits (if applicable): Eligible for medical/dental/vision, 401(k) with match, short/long-term disability, 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.
Application instructions: Apply via the “Apply” button (acknowledging privacy notice and terms of use).