Lead Clinical Study Manager
Takeda
June 25, 2026
Remote
United States
$116,000 - $182,270 USD yearly
Clinical Research and Development
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Lead Clinical Study Manager (Remote).
Responsibilities:
- Lead study operational strategy, planning, and execution for assigned clinical program(s) in compliance with ICH GCP, local regulations, and Takeda SOPs—on schedule and on budget.
- Oversee strategic partners/CROs and other vendors; provide operational oversight and guidance to rapidly resolve issues.
- Lead early engagement to develop operational strategy with robust risk management.
- Provide sponsor oversight (monitoring plans/documents, study plans, meeting management, protocol deviation trends, issue/risk/decision review with mitigation).
- Manage study budget planning and external spend; ensure budgets, enrollment, and gating are accurate; serve as escalation point for third parties.
- Partner with data management to pressure test database timelines and linkage to database lock/CSR.
- Ensure studies are “inspection ready”; may support regulatory inspections.
- Represent role in working groups; onboard/mentor new or junior CSMs.
Qualifications & Skills:
- BS/BA required (health/life science/technology or equivalent). Advanced degree preferred.
- 6+ years pharma/CRO experience; 4+ years clinical study management/oversight, including early phase or Phase 2/3 plus global/international programs; multiple therapeutic areas advantageous.
- Knowledge of global regulatory/compliance (US CFR, EU CTD, ICH GCP) and local requirements.
- Demonstrated project/program management and matrix leadership; excellent communication, teamwork, organization, interpersonal and problem-solving; fluent business English.
Travel: ~5–20%.
Benefits (as stated): medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, wellbeing benefits, up to 80 hours sick time/year, up to 120 hours paid vacation for new hires, and eligibility for incentives.
Lead Clinical Study Manager (Remote).
Responsibilities:
- Lead study operational strategy, planning, and execution for assigned clinical program(s) in compliance with ICH GCP, local regulations, and Takeda SOPs—on schedule and on budget.
- Oversee strategic partners/CROs and other vendors; provide operational oversight and guidance to rapidly resolve issues.
- Lead early engagement to develop operational strategy with robust risk management.
- Provide sponsor oversight (monitoring plans/documents, study plans, meeting management, protocol deviation trends, issue/risk/decision review with mitigation).
- Manage study budget planning and external spend; ensure budgets, enrollment, and gating are accurate; serve as escalation point for third parties.
- Partner with data management to pressure test database timelines and linkage to database lock/CSR.
- Ensure studies are “inspection ready”; may support regulatory inspections.
- Represent role in working groups; onboard/mentor new or junior CSMs.
Qualifications & Skills:
- BS/BA required (health/life science/technology or equivalent). Advanced degree preferred.
- 6+ years pharma/CRO experience; 4+ years clinical study management/oversight, including early phase or Phase 2/3 plus global/international programs; multiple therapeutic areas advantageous.
- Knowledge of global regulatory/compliance (US CFR, EU CTD, ICH GCP) and local requirements.
- Demonstrated project/program management and matrix leadership; excellent communication, teamwork, organization, interpersonal and problem-solving; fluent business English.
Travel: ~5–20%.
Benefits (as stated): medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, wellbeing benefits, up to 80 hours sick time/year, up to 120 hours paid vacation for new hires, and eligibility for incentives.