Lead Clinical Study Manager
Takeda
2 months ago
Remote
United States
$116,000 - $182,270 USD yearly
Clinical Research and Development
Lead study operational strategy and planning; oversee execution of clinical studies for assigned clinical program(s) aligned to the Clinical Development Plan.
- Oversee study execution per ICH-GCP, local regulations, and Takeda SOPs; ensure on schedule/on budget.
- Oversee Strategic Partners/CROs/vendors; ensure obligations are met.
- Provide SME input into protocol synopsis/final protocol and study documents; ensure operational feasibility (patient/site burden).
- Validate budgets and address impacts; support country/site feasibility and selection.
- Lead Operational Strategy during early engagement; ensure assumptions and robust risk management.
- Provide oversight/support to resolve study issues rapidly.
- Own study budget planning/management and communicate status/cost/issues; serve as escalation point for vendors.
- Oversee partner/CRO/vendor selection, budgeting, contract negotiation, and performance supervision.
- Sponsor oversight: monitoring plans/documents, study plans, meeting management, protocol deviations trend review, risk/issue/decision monitoring.
- Partner with data management on database timelines/lock and CSR planning; ensure inspection readiness.
- Represent role in initiatives/working groups; onboard/mentor new/junior CSMs.
Qualifications/Requirements
- BS/BA (health/life science/technology) or equivalent; advanced degree may supplement.
- 6+ years pharma and/or CRO clinical research; 4+ years clinical study management/oversight; early phase or Phase 2/3; global/international experience; multi-therapeutic area advantageous.
- Knowledge of global regulatory/compliance (US CFR, EU CTD, ICH GCP) and local requirements.
- Strong project/program management, matrix leadership, communication, teamwork, and problem-solving; fluent business English.
Travel: ~5–20%.
Benefits (explicitly stated)
- Base salary: $111,800–$175,670; incentives possible.
- Medical/dental/vision, 401(k) + match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 sick hours/year; up to 120 paid vacation hours for new hires.
- Oversee study execution per ICH-GCP, local regulations, and Takeda SOPs; ensure on schedule/on budget.
- Oversee Strategic Partners/CROs/vendors; ensure obligations are met.
- Provide SME input into protocol synopsis/final protocol and study documents; ensure operational feasibility (patient/site burden).
- Validate budgets and address impacts; support country/site feasibility and selection.
- Lead Operational Strategy during early engagement; ensure assumptions and robust risk management.
- Provide oversight/support to resolve study issues rapidly.
- Own study budget planning/management and communicate status/cost/issues; serve as escalation point for vendors.
- Oversee partner/CRO/vendor selection, budgeting, contract negotiation, and performance supervision.
- Sponsor oversight: monitoring plans/documents, study plans, meeting management, protocol deviations trend review, risk/issue/decision monitoring.
- Partner with data management on database timelines/lock and CSR planning; ensure inspection readiness.
- Represent role in initiatives/working groups; onboard/mentor new/junior CSMs.
Qualifications/Requirements
- BS/BA (health/life science/technology) or equivalent; advanced degree may supplement.
- 6+ years pharma and/or CRO clinical research; 4+ years clinical study management/oversight; early phase or Phase 2/3; global/international experience; multi-therapeutic area advantageous.
- Knowledge of global regulatory/compliance (US CFR, EU CTD, ICH GCP) and local requirements.
- Strong project/program management, matrix leadership, communication, teamwork, and problem-solving; fluent business English.
Travel: ~5–20%.
Benefits (explicitly stated)
- Base salary: $111,800–$175,670; incentives possible.
- Medical/dental/vision, 401(k) + match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 sick hours/year; up to 120 paid vacation hours for new hires.