Lead Clinical Study Manager
Takeda
August 25, 2026
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 the Clinical Development Plan.
Responsibilities
- Lead cross-functional study execution team (SET) to meet study objectives in compliance with ICH GCP, local regulations, and Takeda SOPs—on schedule and on budget.
- Oversee Strategic Partners/CROs/vendors to meet ICH-GCP obligations and business objectives.
- Provide operational strategy and risk management during early engagement; develop Operational Strategy for review.
- Validate study budget and manage external spend; ensure budgets/updates and enrollment are accurate; serve as escalation point.
- Provide oversight/support/guidance to partners/vendors to identify/mitigate risks and resolve issues.
- Oversee vendor selection, budget, and contract negotiation; supervise performance and escalate to governance committees when warranted.
- Sponsor oversight: review/approve monitoring documents, review/endorse study plans, review protocol deviations trends, monitor issues/risks/decisions and mitigations.
- Partner with data management/statistics/regulatory on database timelines/DBL/CSR delivery alignment.
- Ensure studies are inspection ready; support inspection preparation/attendance as SME.
- Represent study management in initiatives; onboard/mentor study management teams.
Qualifications & Skills
- BS/BA required (health/life science/technology preferred) or equivalent.
- 6+ years pharma and/or CRO experience; 4+ years clinical study management/oversight; early phase or Phase 2/3 and global/international studies; more than one therapeutic area advantageous.
- Advanced degree and relevant training may supplement requirements.
- Knowledge of global clinical regulatory/compliance (US CFR, EU CTR, ICH GCP) and local requirements.
- Strong project/program management, matrix leadership, communication, teamwork, organization, interpersonal and problem-solving skills; fluent business English.
- Travel 5–20% (overnight/international).
Compensation/Benefits (explicit)
- U.S. 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 time off, holidays, well-being benefits, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.
Responsibilities
- Lead cross-functional study execution team (SET) to meet study objectives in compliance with ICH GCP, local regulations, and Takeda SOPs—on schedule and on budget.
- Oversee Strategic Partners/CROs/vendors to meet ICH-GCP obligations and business objectives.
- Provide operational strategy and risk management during early engagement; develop Operational Strategy for review.
- Validate study budget and manage external spend; ensure budgets/updates and enrollment are accurate; serve as escalation point.
- Provide oversight/support/guidance to partners/vendors to identify/mitigate risks and resolve issues.
- Oversee vendor selection, budget, and contract negotiation; supervise performance and escalate to governance committees when warranted.
- Sponsor oversight: review/approve monitoring documents, review/endorse study plans, review protocol deviations trends, monitor issues/risks/decisions and mitigations.
- Partner with data management/statistics/regulatory on database timelines/DBL/CSR delivery alignment.
- Ensure studies are inspection ready; support inspection preparation/attendance as SME.
- Represent study management in initiatives; onboard/mentor study management teams.
Qualifications & Skills
- BS/BA required (health/life science/technology preferred) or equivalent.
- 6+ years pharma and/or CRO experience; 4+ years clinical study management/oversight; early phase or Phase 2/3 and global/international studies; more than one therapeutic area advantageous.
- Advanced degree and relevant training may supplement requirements.
- Knowledge of global clinical regulatory/compliance (US CFR, EU CTR, ICH GCP) and local requirements.
- Strong project/program management, matrix leadership, communication, teamwork, organization, interpersonal and problem-solving skills; fluent business English.
- Travel 5–20% (overnight/international).
Compensation/Benefits (explicit)
- U.S. 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 time off, holidays, well-being benefits, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.