Clinical Study Manager
Takeda
15 days ago
Remote
United States
$103,500 - $162,690 USD yearly
Clinical Research and Development
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Job Description (Clinical Study Manager – Remote):
Lead study operational strategy and planning and oversee execution of clinical studies for assigned clinical program(s) in line with the Clinical Development Plan. In collaboration with Clinical Operations Program Lead(s), oversee study execution (ICH-GCP, local regulations, Takeda SOPs) on schedule and budget; manage/partner with Strategic Partners, CROs, and vendors; ensure operational feasibility (patient/site burden) and timelines; provide study document/protocol operational input; validate study budgets and manage external spend; participate in country/site feasibility and selection; onboard team members/vendors; lead operational strategy during early engagement and ensure robust risk management; provide oversight/support to resolve study issues; supervise vendor selection/contracting and performance.
Qualifications & Skills:
- BS/BA required (health/life science/technology or equivalent).
- Advanced degree may supplement.
- 5+ years pharma/CRO experience; 3+ years clinical study management/oversight with significant support (e.g., assistant/associate, or lead CRA).
- Global regulatory/compliance knowledge (US CFR, EU CTD, ICH GCP) and local requirements.
- Demonstrated project/program management and matrix leadership; strong communication; teamwork/organizational/interpersonal/problem-solving; fluent business English.
Benefits (U.S. employees may be eligible): incentives; medical/dental/vision; 401(k) match; disability; life insurance; tuition reimbursement; paid volunteer time off; holidays; well-being; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Job Description (Clinical Study Manager – Remote):
Lead study operational strategy and planning and oversee execution of clinical studies for assigned clinical program(s) in line with the Clinical Development Plan. In collaboration with Clinical Operations Program Lead(s), oversee study execution (ICH-GCP, local regulations, Takeda SOPs) on schedule and budget; manage/partner with Strategic Partners, CROs, and vendors; ensure operational feasibility (patient/site burden) and timelines; provide study document/protocol operational input; validate study budgets and manage external spend; participate in country/site feasibility and selection; onboard team members/vendors; lead operational strategy during early engagement and ensure robust risk management; provide oversight/support to resolve study issues; supervise vendor selection/contracting and performance.
Qualifications & Skills:
- BS/BA required (health/life science/technology or equivalent).
- Advanced degree may supplement.
- 5+ years pharma/CRO experience; 3+ years clinical study management/oversight with significant support (e.g., assistant/associate, or lead CRA).
- Global regulatory/compliance knowledge (US CFR, EU CTD, ICH GCP) and local requirements.
- Demonstrated project/program management and matrix leadership; strong communication; teamwork/organizational/interpersonal/problem-solving; fluent business English.
Benefits (U.S. employees may be eligible): incentives; medical/dental/vision; 401(k) match; disability; life insurance; tuition reimbursement; paid volunteer time off; holidays; well-being; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.