Lead Clinical Study Manager
Takeda
8 hours ago
Remote
United States
$116,000 - $182,270 USD yearly
Clinical Research and Development
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Lead Clinical Study Manager (remote)
Goals/Responsibilities:
- Lead study operational strategy, planning, and execution for assigned clinical program(s) aligned to the Clinical Development Plan.
- Oversee study execution in compliance with ICH-GCP, local regulations, and Takeda SOPs; ensure studies are on schedule and on budget.
- Oversee strategic partners/CROs/vendors to meet ICH-GCP obligations and business objectives.
- Accountable for operational strategy and execution of assigned clinical trials.
- Provide input into protocol synopsis/final protocol and study documents; ensure operational feasibility (patient/site burden).
- Validate budget and address impacts; support country/site feasibility/selection.
- Lead operational strategy during early engagement; ensure robust risk management.
- Provide oversight/guidance to partners/CROs to resolve issues rapidly.
- Own study budget planning/management and external spend; communicate status/cost/issues; serve as escalation point.
- Oversee vendor selection, budget/contract negotiation, and performance supervision.
- Sponsor oversight: review monitoring documents, study plans, meeting management, protocol deviation trends, and issue/risk/decision mitigation.
- Ensure database timelines and link strategy to database lock/CSR with data management.
- Keep studies inspection-ready; may support regulatory inspections.
- Represent role in working groups; support onboarding/mentoring.
Qualifications:
- BS/BA required (health/life science/technology) or equivalent.
- 6+ years pharma/CRO experience; 4+ years clinical study management/oversight; early phase or Phase 2/3; global/international; multiple TA advantageous.
- Knowledge of global regulatory/compliance (US CFR, EU CTD, ICH GCP) and awareness of local requirements.
- Strong project/program management, matrix leadership, communication, teamwork, and problem-solving; fluent business English.
Travel: 5–20%.
Benefits (explicitly stated): medical/dental/vision, 401(k) + match, disability, basic life, tuition reimbursement, paid volunteer time off, paid holidays, well-being benefits, up to 80 hours sick time/year, up to 120 hours paid vacation (new hires).
Lead Clinical Study Manager (remote)
Goals/Responsibilities:
- Lead study operational strategy, planning, and execution for assigned clinical program(s) aligned to the Clinical Development Plan.
- Oversee study execution in compliance with ICH-GCP, local regulations, and Takeda SOPs; ensure studies are on schedule and on budget.
- Oversee strategic partners/CROs/vendors to meet ICH-GCP obligations and business objectives.
- Accountable for operational strategy and execution of assigned clinical trials.
- Provide input into protocol synopsis/final protocol and study documents; ensure operational feasibility (patient/site burden).
- Validate budget and address impacts; support country/site feasibility/selection.
- Lead operational strategy during early engagement; ensure robust risk management.
- Provide oversight/guidance to partners/CROs to resolve issues rapidly.
- Own study budget planning/management and external spend; communicate status/cost/issues; serve as escalation point.
- Oversee vendor selection, budget/contract negotiation, and performance supervision.
- Sponsor oversight: review monitoring documents, study plans, meeting management, protocol deviation trends, and issue/risk/decision mitigation.
- Ensure database timelines and link strategy to database lock/CSR with data management.
- Keep studies inspection-ready; may support regulatory inspections.
- Represent role in working groups; support onboarding/mentoring.
Qualifications:
- BS/BA required (health/life science/technology) or equivalent.
- 6+ years pharma/CRO experience; 4+ years clinical study management/oversight; early phase or Phase 2/3; global/international; multiple TA advantageous.
- Knowledge of global regulatory/compliance (US CFR, EU CTD, ICH GCP) and awareness of local requirements.
- Strong project/program management, matrix leadership, communication, teamwork, and problem-solving; fluent business English.
Travel: 5–20%.
Benefits (explicitly stated): medical/dental/vision, 401(k) + match, disability, basic life, tuition reimbursement, paid volunteer time off, paid holidays, well-being benefits, up to 80 hours sick time/year, up to 120 hours paid vacation (new hires).