Manager Clinical Study Lead
Regeneron
August 15, 2026
On-site
Armonk, NY
Clinical Research and Development
Responsibilities:
- Accountable for global execution of assigned smaller/less complex clinical trials from study design through closeout; ensure study timelines, budget, and conduct in accordance with SOPs and ICH/GCP.
- Lead cross-functional study team; oversee delivery against timelines, deliverables, and budget; raise issues and implement corrective actions.
- Provide operational input into protocol development; lead feasibility assessments, site evaluation/selection, and investigator meeting preparation/execution.
- Oversee study documentation (e.g., CRFs, data management plan, monitoring plan/oversight plan, training plan, data review plan, statistical analysis plan).
- Oversee study systems (e.g., CTMS, TMF) and ensure clinical trial registry compliance.
- Identify outsourcing needs; lead vendor engagement, contracting, and management to ensure scope-of-work alignment.
- Lead study-level risk assessment/mitigation; oversee activation/monitoring, deviations, and patient recruitment/retention strategy implementation.
- Manage close-out (database lock, vendor contract reconciliation, budget, TMF, study drug accountability); contribute to CSR writing/review and lessons learned.
- Supervise CTM staff and assign tasks; drive process improvements and continuous improvement of CTM SOPs.
Qualifications & Skills:
- Bachelor’s degree + at least 6 years relevant industry experience.
- Extensive budget management; ability to build study teams/collaborations; demonstrated vendor management.
- Proficiency with trial management systems and Microsoft (Project, PowerPoint, Word, Excel), plus IVRS/IWRS and EDC.
- Global clinical trial operations experience; strong knowledge of ICH/GCP and regulatory guidelines; project management and cross-functional leadership.
Application:
- Apply now.
- Accountable for global execution of assigned smaller/less complex clinical trials from study design through closeout; ensure study timelines, budget, and conduct in accordance with SOPs and ICH/GCP.
- Lead cross-functional study team; oversee delivery against timelines, deliverables, and budget; raise issues and implement corrective actions.
- Provide operational input into protocol development; lead feasibility assessments, site evaluation/selection, and investigator meeting preparation/execution.
- Oversee study documentation (e.g., CRFs, data management plan, monitoring plan/oversight plan, training plan, data review plan, statistical analysis plan).
- Oversee study systems (e.g., CTMS, TMF) and ensure clinical trial registry compliance.
- Identify outsourcing needs; lead vendor engagement, contracting, and management to ensure scope-of-work alignment.
- Lead study-level risk assessment/mitigation; oversee activation/monitoring, deviations, and patient recruitment/retention strategy implementation.
- Manage close-out (database lock, vendor contract reconciliation, budget, TMF, study drug accountability); contribute to CSR writing/review and lessons learned.
- Supervise CTM staff and assign tasks; drive process improvements and continuous improvement of CTM SOPs.
Qualifications & Skills:
- Bachelor’s degree + at least 6 years relevant industry experience.
- Extensive budget management; ability to build study teams/collaborations; demonstrated vendor management.
- Proficiency with trial management systems and Microsoft (Project, PowerPoint, Word, Excel), plus IVRS/IWRS and EDC.
- Global clinical trial operations experience; strong knowledge of ICH/GCP and regulatory guidelines; project management and cross-functional leadership.
Application:
- Apply now.