Manager, Clinical Study Lead
Regeneron
August 08, 2026
On-site
Warren, NJ
Clinical Research and Development
Responsibilities:
- Accountable for global execution of assigned smaller/less complex clinical trials (including Phase IV/Real World Evidence) from study design through close-out; oversee study timelines, budget, and conduct per Regeneron SOPs and ICH/GCP.
- Lead cross-functional study team delivery; act as primary leadership/oversight point of contact; ensure execution against timelines, deliverables, and budget; raise issues and implement corrective actions.
- Provide operational input into protocol development; lead feasibility assessments; oversee site evaluation/selection; lead investigator meeting preparation and execution.
- Oversee/contribute to study documentation (e.g., CRFs, data/monitoring plans, training plan, data review plan, SAP).
- Oversee setup/maintenance of study systems (e.g., CTMS, TMF) and ensure clinical trial registry compliance.
- Identify outsourcing needs; lead CRO/vendor engagement, contracting, and management.
- Manage baseline budget/timeline; ensure scope change control.
- Lead risk assessment/mitigation; monitor site activation/visits; implement patient recruitment/retention strategies; monitor data entry/query resolution.
- Manage study close-out (database lock, reconciliation of contracts/budget/TMF/drug accountability); contribute to CSRs and lessons learned.
- Assign tasks and directly supervise CTM staff; support process improvements and continuous improvement of CTM SOPs.
- May handle unmasked study activities (e.g., unmasked TMF/data review, IVRS issues, unmasked monitoring oversight).
Qualifications:
- Bachelor’s degree and at least 6 years relevant industry experience.
- Extensive budget management; proven ability to build study teams/collaborations; demonstrated vendor management.
- Technical proficiency with trial management systems and Microsoft (Project, PowerPoint, Word, Excel); IVRS/IWRS and EDC.
- Global clinical trial operations experience (protocols/key documents); strong ICH/GCP and regulatory knowledge; project management and cross-functional leadership.
- Ability to apply operational strategic direction for studies.
- Phase IV/RWE experience preferred.
Application:
- Apply now.
- Accountable for global execution of assigned smaller/less complex clinical trials (including Phase IV/Real World Evidence) from study design through close-out; oversee study timelines, budget, and conduct per Regeneron SOPs and ICH/GCP.
- Lead cross-functional study team delivery; act as primary leadership/oversight point of contact; ensure execution against timelines, deliverables, and budget; raise issues and implement corrective actions.
- Provide operational input into protocol development; lead feasibility assessments; oversee site evaluation/selection; lead investigator meeting preparation and execution.
- Oversee/contribute to study documentation (e.g., CRFs, data/monitoring plans, training plan, data review plan, SAP).
- Oversee setup/maintenance of study systems (e.g., CTMS, TMF) and ensure clinical trial registry compliance.
- Identify outsourcing needs; lead CRO/vendor engagement, contracting, and management.
- Manage baseline budget/timeline; ensure scope change control.
- Lead risk assessment/mitigation; monitor site activation/visits; implement patient recruitment/retention strategies; monitor data entry/query resolution.
- Manage study close-out (database lock, reconciliation of contracts/budget/TMF/drug accountability); contribute to CSRs and lessons learned.
- Assign tasks and directly supervise CTM staff; support process improvements and continuous improvement of CTM SOPs.
- May handle unmasked study activities (e.g., unmasked TMF/data review, IVRS issues, unmasked monitoring oversight).
Qualifications:
- Bachelor’s degree and at least 6 years relevant industry experience.
- Extensive budget management; proven ability to build study teams/collaborations; demonstrated vendor management.
- Technical proficiency with trial management systems and Microsoft (Project, PowerPoint, Word, Excel); IVRS/IWRS and EDC.
- Global clinical trial operations experience (protocols/key documents); strong ICH/GCP and regulatory knowledge; project management and cross-functional leadership.
- Ability to apply operational strategic direction for studies.
- Phase IV/RWE experience preferred.
Application:
- Apply now.