Clinical Study Manager
Takeda
5 hours ago
Remote
United States
$103,500 - $162,690 USD yearly
Clinical Research and Development
Clinical Study Manager (Remote; Massachusetts - Virtual)
GOALS
- Lead study operational strategy, planning, and oversee execution of clinical studies for an assigned clinical program(s) aligned to the Clinical Development Plan.
- Collaborate with Clinical Operations Program Lead(s) and oversee study execution in compliance with ICH-GCP, local regulations, and Takeda SOPs.
ACCOUNTABILITIES / RESPONSIBILITIES
- Oversee execution of low to medium complexity studies (may include multiple studies/programs) on schedule and within budget.
- Oversee Strategic Partners, CROs, and vendors to meet ICH-GCP obligations and business objectives.
- Provide operational input to protocol synopsis, final protocol, and study documents; ensure patient/site burden is feasible.
- Lead early engagement operational strategy with robust risk management; provide oversight/support to resolve issues.
- Plan/manage study budget and external spend; ensure accuracy of budgets, enrollment, and gating; communicate status/cost/issues; serve as escalation point.
- Support vendor selection and contract negotiation; supervise performance and escalate as needed.
- Sponsor oversight: review/approve monitoring documents; endorse study plans; manage study team meetings; review protocol deviations trends; monitor risks/issues/decisions and mitigations.
- Ensure studies are inspection ready.
QUALIFICATIONS / REQUIRED SKILLS
- BS/BA required (health/life sciences/technology preferred) or equivalent.
- 5+ years pharma and/or CRO experience; 3+ years clinical study management/oversight with significant study management support (e.g., assistant/associate or lead CRA).
- Knowledge of global regulatory/compliance requirements (US CFR, EU CTD, ICH GCP) and awareness of local country requirements.
- Demonstrated project/program management and matrix leadership; strong communication; teamwork/organization/problem-solving; fluent business English.
EDUCATION/OTHER
- Advanced degree(s) and relevant training/experience may supplement.
- Experience with Phase 2/3 and/or global/international programs; multiple therapeutic areas advantageous.
BENEFITS (as stated)
- Medical/dental/vision, 401(k) match, disability and life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation for new hires; may be eligible for incentives.
GOALS
- Lead study operational strategy, planning, and oversee execution of clinical studies for an assigned clinical program(s) aligned to the Clinical Development Plan.
- Collaborate with Clinical Operations Program Lead(s) and oversee study execution in compliance with ICH-GCP, local regulations, and Takeda SOPs.
ACCOUNTABILITIES / RESPONSIBILITIES
- Oversee execution of low to medium complexity studies (may include multiple studies/programs) on schedule and within budget.
- Oversee Strategic Partners, CROs, and vendors to meet ICH-GCP obligations and business objectives.
- Provide operational input to protocol synopsis, final protocol, and study documents; ensure patient/site burden is feasible.
- Lead early engagement operational strategy with robust risk management; provide oversight/support to resolve issues.
- Plan/manage study budget and external spend; ensure accuracy of budgets, enrollment, and gating; communicate status/cost/issues; serve as escalation point.
- Support vendor selection and contract negotiation; supervise performance and escalate as needed.
- Sponsor oversight: review/approve monitoring documents; endorse study plans; manage study team meetings; review protocol deviations trends; monitor risks/issues/decisions and mitigations.
- Ensure studies are inspection ready.
QUALIFICATIONS / REQUIRED SKILLS
- BS/BA required (health/life sciences/technology preferred) or equivalent.
- 5+ years pharma and/or CRO experience; 3+ years clinical study management/oversight with significant study management support (e.g., assistant/associate or lead CRA).
- Knowledge of global regulatory/compliance requirements (US CFR, EU CTD, ICH GCP) and awareness of local country requirements.
- Demonstrated project/program management and matrix leadership; strong communication; teamwork/organization/problem-solving; fluent business English.
EDUCATION/OTHER
- Advanced degree(s) and relevant training/experience may supplement.
- Experience with Phase 2/3 and/or global/international programs; multiple therapeutic areas advantageous.
BENEFITS (as stated)
- Medical/dental/vision, 401(k) match, disability and life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation for new hires; may be eligible for incentives.