Lead Clinical Study Manager
Takeda
June 25, 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) in close collaboration with Clinical Operations Program Lead(s).
Responsibilities
- Oversee execution of studies in compliance with ICH GCP, local regulations, and Takeda SOPs; ensure on schedule and on budget.
- Oversee strategic partners/CROs and 3rd-party vendors to meet ICH-GCP and business objectives.
- Provide SME input into protocol synopsis, final protocol, and other study documents.
- Challenge feasibility (patient/site burden) and ensure timelines meet the clinical development plan.
- Validate budget and ensure impacts are addressed.
- Participate in country/site feasibility and selection; provide country insights, alignment, and therapeutic expertise.
- Ensure onboarding of new team members and vendors.
- During early engagement, lead operational strategy development with robust risk management.
- Provide oversight/support/guidance to partners/CROs to rapidly resolve issues.
- Own study budget planning/management and external spend; communicate study status, costs, and issues; serve as escalation point.
- Oversee partner/CRO/vendor selection, contract negotiation, and performance supervision; escalate to governance as needed.
- Sponsor oversight: review/approval of monitoring plans, endorse study plans, manage study team meetings, review protocol deviations trends, and document/risk-mitigate issues.
- In partnership with data management, pressure test database timelines/plan; ensure linkage to database lock and CSR.
- Ensure inspection readiness and support regulatory inspections.
- Represent role in initiatives/working groups; help onboard/mentor new/junior CSMs.
Qualifications
- BS/BA required (health/life science/technology) or equivalent.
- Master/Doctorate and relevant training/experience preferred/considered.
- 6+ years in pharma and/or CRO; 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 requirements.
- Demonstrated project/program management and matrix leadership.
- Excellent communication; teamwork/organizational/interpersonal/problem-solving; fluent business English.
Travel: ~5–20%.
Benefits: Medical, dental, vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being; up to 80 hours sick time and up to 120 hours paid vacation for new hires (per year).
Application instructions: Apply via the “Apply” button and complete the employment application.
Responsibilities
- Oversee execution of studies in compliance with ICH GCP, local regulations, and Takeda SOPs; ensure on schedule and on budget.
- Oversee strategic partners/CROs and 3rd-party vendors to meet ICH-GCP and business objectives.
- Provide SME input into protocol synopsis, final protocol, and other study documents.
- Challenge feasibility (patient/site burden) and ensure timelines meet the clinical development plan.
- Validate budget and ensure impacts are addressed.
- Participate in country/site feasibility and selection; provide country insights, alignment, and therapeutic expertise.
- Ensure onboarding of new team members and vendors.
- During early engagement, lead operational strategy development with robust risk management.
- Provide oversight/support/guidance to partners/CROs to rapidly resolve issues.
- Own study budget planning/management and external spend; communicate study status, costs, and issues; serve as escalation point.
- Oversee partner/CRO/vendor selection, contract negotiation, and performance supervision; escalate to governance as needed.
- Sponsor oversight: review/approval of monitoring plans, endorse study plans, manage study team meetings, review protocol deviations trends, and document/risk-mitigate issues.
- In partnership with data management, pressure test database timelines/plan; ensure linkage to database lock and CSR.
- Ensure inspection readiness and support regulatory inspections.
- Represent role in initiatives/working groups; help onboard/mentor new/junior CSMs.
Qualifications
- BS/BA required (health/life science/technology) or equivalent.
- Master/Doctorate and relevant training/experience preferred/considered.
- 6+ years in pharma and/or CRO; 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 requirements.
- Demonstrated project/program management and matrix leadership.
- Excellent communication; teamwork/organizational/interpersonal/problem-solving; fluent business English.
Travel: ~5–20%.
Benefits: Medical, dental, vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being; up to 80 hours sick time and up to 120 hours paid vacation for new hires (per year).
Application instructions: Apply via the “Apply” button and complete the employment application.