Lead Clinical Study Manager
Takeda
15 days ago
Remote
United States
$116,000 - $182,270 USD yearly
Clinical Research and Development
Lead study operational strategy and planning and oversee execution of clinical studies for assigned clinical program(s), supporting clinical strategy in the Clinical Development Plan.
Responsibilities:
- Oversee execution of studies in assigned programs in compliance with quality standards (ICH GCP, local regulations, Takeda SOPs) on schedule and on budget.
- Oversee Strategic Partners/CROs/vendors to meet obligations under ICH-GCP and business objectives.
- Accountable for planning, operational strategy, and execution for assigned clinical trials; provide operational input into protocol synopsis, final protocol, and study documents.
- Challenge study teams on operational feasibility (patient/site burden) and timelines; validate budget and ensure impacts are addressed.
- Participate in country/site feasibility and selection.
- Lead operational strategy development during early engagement (assumptions, robust risk management) and provide oversight/support to partners/CROs to resolve study issues rapidly.
- Plan/manage study budgets and external spend; partner with COPLs, Global Program Management, and Finance to ensure budgets/enrollment/gating accuracy; communicate status/cost/issues; act as escalation point.
- Oversee vendor selection, budget/contract negotiation, supervision, and escalation to governance committees when warranted.
- Sponsor oversight: review/approve monitoring documents; review/endorse study plans; manage/attend study meetings as needed; review protocol deviations and trends; monitor issues/risks/decisions and ensure mitigation.
- In partnership with data management, pressure test database timelines/plans; ensure linkage to database lock and CSR.
- Ensure inspection readiness; support regulatory inspections.
- Represent role in working groups; onboard/mentor new or junior CSMs; assist program COPL as required.
Qualifications:
- BS/BA required (health/life science/technology or equivalent).
- Advanced degree may supplement.
- 6+ years pharma and/or CRO experience, including 4+ years clinical study management/oversight; early phase or Phase 2/3; global/international programs; more than one therapeutic area advantageous.
- Knowledge of global regulatory/compliance requirements (e.g., US CFR, EU CTD, ICH GCP) and local requirements.
- Demonstrated project/program management and matrix leadership.
- Excellent communication; teamwork/organizational/interpersonal/problem-solving.
- Fluent business English (oral/written).
Travel: ~5–20%.
Benefits (as stated): medical/dental/vision insurance, 401(k) + match, short-/long-term disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.
Application instructions: Apply via the “Apply” button.
Responsibilities:
- Oversee execution of studies in assigned programs in compliance with quality standards (ICH GCP, local regulations, Takeda SOPs) on schedule and on budget.
- Oversee Strategic Partners/CROs/vendors to meet obligations under ICH-GCP and business objectives.
- Accountable for planning, operational strategy, and execution for assigned clinical trials; provide operational input into protocol synopsis, final protocol, and study documents.
- Challenge study teams on operational feasibility (patient/site burden) and timelines; validate budget and ensure impacts are addressed.
- Participate in country/site feasibility and selection.
- Lead operational strategy development during early engagement (assumptions, robust risk management) and provide oversight/support to partners/CROs to resolve study issues rapidly.
- Plan/manage study budgets and external spend; partner with COPLs, Global Program Management, and Finance to ensure budgets/enrollment/gating accuracy; communicate status/cost/issues; act as escalation point.
- Oversee vendor selection, budget/contract negotiation, supervision, and escalation to governance committees when warranted.
- Sponsor oversight: review/approve monitoring documents; review/endorse study plans; manage/attend study meetings as needed; review protocol deviations and trends; monitor issues/risks/decisions and ensure mitigation.
- In partnership with data management, pressure test database timelines/plans; ensure linkage to database lock and CSR.
- Ensure inspection readiness; support regulatory inspections.
- Represent role in working groups; onboard/mentor new or junior CSMs; assist program COPL as required.
Qualifications:
- BS/BA required (health/life science/technology or equivalent).
- Advanced degree may supplement.
- 6+ years pharma and/or CRO experience, including 4+ years clinical study management/oversight; early phase or Phase 2/3; global/international programs; more than one therapeutic area advantageous.
- Knowledge of global regulatory/compliance requirements (e.g., US CFR, EU CTD, ICH GCP) and local requirements.
- Demonstrated project/program management and matrix leadership.
- Excellent communication; teamwork/organizational/interpersonal/problem-solving.
- Fluent business English (oral/written).
Travel: ~5–20%.
Benefits (as stated): medical/dental/vision insurance, 401(k) + match, short-/long-term disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.
Application instructions: Apply via the “Apply” button.