Manager, Clinical Study Lead
Regeneron
June 25, 2026
Remote friendly (Warren, NJ)
United States
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; ensure timelines and budget, and study conduct per SOPs and ICH/GCP.
- Lead cross-functional study team for clinical study delivery; oversee execution against timelines/deliverables/budget; raise issues and implement corrective actions.
- Provide operational input into protocol development; lead feasibility assessments; oversee site evaluation/selection; lead investigator meeting preparation/execution.
- Oversee study documentation (e.g., CRFs, data management plan, monitoring plan/oversight plan, training plan, data review plan, SAP).
- Set up/maintain study systems (e.g., CTMS, TMF) and ensure clinical trial registry compliance.
- Identify outsourcing needs; lead vendor engagement, contracting, and management to ensure CRO/vendor delivery per scope.
- Provide input into baseline budget/timeline; manage budget and scope change control.
- Lead study-level risk assessment/mitigation; monitor site activation/visits and deviations; oversee recruitment/retention strategies; monitor data entry/query resolution.
- Manage close-out activities (database lock, reconciliation of contracts/budget/TMF, study drug accountability); contribute to clinical study report writing/review; facilitate lessons learned.
- Assign tasks to Clinical Study Management staff; directly supervise CTM staff; support deliverables and continuous improvement.
- May perform unmasked-study tasks (e.g., unmasked TMF setup/management, IVRS issue point of contact, oversight of unmasked monitoring).
Qualifications/Requirements:
- Bachelor’s degree; at least 6 years relevant industry experience.
- Extensive budget management; experience building 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 and key study documents); solid ICH/GCP and regulatory knowledge; project management and cross-functional leadership.
- Ability to implement operational strategic direction/guidance for clinical studies.
Preferred:
- Experience with Phase IV / RWE.
Application instruction:
- 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; ensure timelines and budget, and study conduct per SOPs and ICH/GCP.
- Lead cross-functional study team for clinical study delivery; oversee execution against timelines/deliverables/budget; raise issues and implement corrective actions.
- Provide operational input into protocol development; lead feasibility assessments; oversee site evaluation/selection; lead investigator meeting preparation/execution.
- Oversee study documentation (e.g., CRFs, data management plan, monitoring plan/oversight plan, training plan, data review plan, SAP).
- Set up/maintain study systems (e.g., CTMS, TMF) and ensure clinical trial registry compliance.
- Identify outsourcing needs; lead vendor engagement, contracting, and management to ensure CRO/vendor delivery per scope.
- Provide input into baseline budget/timeline; manage budget and scope change control.
- Lead study-level risk assessment/mitigation; monitor site activation/visits and deviations; oversee recruitment/retention strategies; monitor data entry/query resolution.
- Manage close-out activities (database lock, reconciliation of contracts/budget/TMF, study drug accountability); contribute to clinical study report writing/review; facilitate lessons learned.
- Assign tasks to Clinical Study Management staff; directly supervise CTM staff; support deliverables and continuous improvement.
- May perform unmasked-study tasks (e.g., unmasked TMF setup/management, IVRS issue point of contact, oversight of unmasked monitoring).
Qualifications/Requirements:
- Bachelor’s degree; at least 6 years relevant industry experience.
- Extensive budget management; experience building 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 and key study documents); solid ICH/GCP and regulatory knowledge; project management and cross-functional leadership.
- Ability to implement operational strategic direction/guidance for clinical studies.
Preferred:
- Experience with Phase IV / RWE.
Application instruction:
- Apply now.