Manager, Clinical Study Lead
Regeneron
August 22, 2026
On-site
Armonk, NY
Clinical Research and Development
Responsibilities:
- Accountable for global execution of assigned smaller/less complex clinical trials from design through close-out; ensure study timelines, budget, and conduct in accordance with SOPs and ICH/GCP.
- Lead cross-functional study team delivery; oversee execution vs. planned timelines, deliverables, and budget; raise issues (conduct, quality, timelines, budget) and implement corrective actions.
- Provide operational input to protocol development; lead feasibility assessments; oversee/conduct site evaluation and selection; lead investigator meeting preparation and execution.
- Oversee study documentation (CRFs, data management plan, monitoring plan/oversight plan, training plan, data review plan, statistical analysis plan, and related materials).
- Oversee set-up/maintenance of study systems (CTMS, TMF) and ensure clinical trial registry compliance.
- Identify outsourcing needs; lead vendor engagement, contracting, and management to ensure delivery to scope.
- Develop/manage baseline budgets and timelines; manage scope change control.
- Lead study risk assessment/mitigation; monitor site activation/visits and deviations; lead patient recruitment/retention strategy implementation; monitor data entry and query resolution.
- Manage close-out (database lock; contract/budget/TMF/reconciliation; study drug accountability); contribute to CSR writing/review and lessons learned.
- Assign/supervise CTM staff and support recruitment, development, training, compliance, and continuous process improvement; may be assigned unmasked tasks for certain studies.
Qualifications/Requirements:
- Bachelor’s degree and at least 6 years of relevant industry experience.
- Extensive budget management; ability to build study teams/collaborations; demonstrated vendor management.
- Technical proficiency with trial management systems and Microsoft Office (Project, PowerPoint, Word, Excel) plus IVRS/IWRS and EDC.
- Global clinical trial operations experience (protocols and key documents); strong ICH/GCP and regulatory knowledge; effective project management and cross-functional leadership.
Skills:
- Trial operations execution, risk management, documentation oversight, vendor/contract management, and team leadership.
Application:
- Apply now.
- Accountable for global execution of assigned smaller/less complex clinical trials from design through close-out; ensure study timelines, budget, and conduct in accordance with SOPs and ICH/GCP.
- Lead cross-functional study team delivery; oversee execution vs. planned timelines, deliverables, and budget; raise issues (conduct, quality, timelines, budget) and implement corrective actions.
- Provide operational input to protocol development; lead feasibility assessments; oversee/conduct site evaluation and selection; lead investigator meeting preparation and execution.
- Oversee study documentation (CRFs, data management plan, monitoring plan/oversight plan, training plan, data review plan, statistical analysis plan, and related materials).
- Oversee set-up/maintenance of study systems (CTMS, TMF) and ensure clinical trial registry compliance.
- Identify outsourcing needs; lead vendor engagement, contracting, and management to ensure delivery to scope.
- Develop/manage baseline budgets and timelines; manage scope change control.
- Lead study risk assessment/mitigation; monitor site activation/visits and deviations; lead patient recruitment/retention strategy implementation; monitor data entry and query resolution.
- Manage close-out (database lock; contract/budget/TMF/reconciliation; study drug accountability); contribute to CSR writing/review and lessons learned.
- Assign/supervise CTM staff and support recruitment, development, training, compliance, and continuous process improvement; may be assigned unmasked tasks for certain studies.
Qualifications/Requirements:
- Bachelor’s degree and at least 6 years of relevant industry experience.
- Extensive budget management; ability to build study teams/collaborations; demonstrated vendor management.
- Technical proficiency with trial management systems and Microsoft Office (Project, PowerPoint, Word, Excel) plus IVRS/IWRS and EDC.
- Global clinical trial operations experience (protocols and key documents); strong ICH/GCP and regulatory knowledge; effective project management and cross-functional leadership.
Skills:
- Trial operations execution, risk management, documentation oversight, vendor/contract management, and team leadership.
Application:
- Apply now.