Lead Clinical Study Manager
Takeda
August 25, 2026
Remote
United States
$116,000 - $182,270 USD yearly
Clinical Research and Development
Objective/Purpose: Lead study operational strategy and planning and oversee execution of clinical studies for assigned clinical program(s) supporting the Clinical Development Plan.
Responsibilities:
- Lead cross-functional Study Execution Team (SET) to meet objectives in compliance with ICH-GCP, local regulations, and Takeda SOPs; deliver on schedule and budget.
- Oversee Strategic Partners/CROs and other vendors to meet ICH-GCP obligations and business objectives.
- Provide operational input into protocol synopsis/final protocol and other study documents.
- Challenge SET for operational feasibility (including patient/site burden) and timeline needs of the clinical development plan.
- Validate budget, manage external spend, and communicate study status/cost/issues; serve as escalation point.
- Lead Operational Strategy development during early partner engagement; ensure assumptions and robust risk management.
- Oversee sponsor oversight activities (e.g., key monitoring plans/documents, protocol deviation review outcomes/trends, issues/risks/decisions mitigation).
- Ensure studies are inspection-ready; may prepare for/attend inspections as SME.
- Support onboarding/mentoring and represent Study Management in working groups.
Qualifications & Required/Preferred Skills:
- BS/BA required (health/life science/tech preferred or equivalent).
- 6+ years pharmaceutical/clinical research org experience; 4+ years clinical study management/oversight; early phase or Phase 2/3; global/international studies; multi-therapeutic area advantageous.
- Knowledge of global regulatory/compliance (US CFR, EU CTR, ICH GCP) and local requirements.
- Advanced degree and relevant training may supplement.
- Project/program management and matrix leadership; strong communication, teamwork, organizational, interpersonal, problem-solving; fluent business English.
Benefits (as stated): Base salary range $116,000–$182,270; may be eligible for incentives and medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off/holidays, well-being; up to 80 hours sick time and up to 120 hours paid vacation for new hires.
Travel: ~5–20% (overnight/international to sites/partners).
Responsibilities:
- Lead cross-functional Study Execution Team (SET) to meet objectives in compliance with ICH-GCP, local regulations, and Takeda SOPs; deliver on schedule and budget.
- Oversee Strategic Partners/CROs and other vendors to meet ICH-GCP obligations and business objectives.
- Provide operational input into protocol synopsis/final protocol and other study documents.
- Challenge SET for operational feasibility (including patient/site burden) and timeline needs of the clinical development plan.
- Validate budget, manage external spend, and communicate study status/cost/issues; serve as escalation point.
- Lead Operational Strategy development during early partner engagement; ensure assumptions and robust risk management.
- Oversee sponsor oversight activities (e.g., key monitoring plans/documents, protocol deviation review outcomes/trends, issues/risks/decisions mitigation).
- Ensure studies are inspection-ready; may prepare for/attend inspections as SME.
- Support onboarding/mentoring and represent Study Management in working groups.
Qualifications & Required/Preferred Skills:
- BS/BA required (health/life science/tech preferred or equivalent).
- 6+ years pharmaceutical/clinical research org experience; 4+ years clinical study management/oversight; early phase or Phase 2/3; global/international studies; multi-therapeutic area advantageous.
- Knowledge of global regulatory/compliance (US CFR, EU CTR, ICH GCP) and local requirements.
- Advanced degree and relevant training may supplement.
- Project/program management and matrix leadership; strong communication, teamwork, organizational, interpersonal, problem-solving; fluent business English.
Benefits (as stated): Base salary range $116,000–$182,270; may be eligible for incentives and medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off/holidays, well-being; up to 80 hours sick time and up to 120 hours paid vacation for new hires.
Travel: ~5–20% (overnight/international to sites/partners).