Manager, Clinical Study Lead
Regeneron
4 hours ago
Remote friendly (Armonk, NY)
United States
Clinical Research and Development
Responsibilities:
- Accountable for global execution of assigned smaller/less complex clinical trials from study design through execution to close out; own study timelines and budget and ensure conduct per SOPs and ICH/GCP.
- Lead cross-functional study team and oversee delivery vs. timelines, deliverables, and budget; raise issues (conduct, quality, timelines, budget) and implement corrective actions.
- Provide operational input into protocol development; lead feasibility assessments; oversee/conduct site evaluation and selection; lead investigator meeting preparation and execution.
- Oversee/contribute to study documentation (e.g., CRFs, data management plan, monitoring plan/oversight plan, training plan, data review plan, statistical analysis plan).
- Oversee setup/maintenance of study systems (CTMS, TMF) and compliance with trial registry requirements.
- Identify outsourcing needs; lead vendor engagement, contracting, and management; ensure CRO/third parties deliver per scope.
- Lead study-level risk assessment/mitigation; monitor site activation/visits; oversee recruitment/retention strategies; monitor data entry and query resolution.
- Manage study close-out (database lock, vendor contract/budget/TMF reconciliation, drug accountability); contribute to CSR writing/review; facilitate lessons learned.
- Supervise CTM staff and assign tasks; recommend process improvements and continuous improvements to CTM SOPs.
Qualifications:
- Bachelor’s degree; 6+ years relevant industry experience.
- Extensive budget, vendor, and study team-building experience.
- Technical proficiency with trial management systems and Microsoft (Project, PowerPoint, Word, Excel); IVRS/IWRS and EDC.
- Global clinical trial operations experience; protocol/document development; strong ICH/GCP and regulatory knowledge; project management and cross-functional leadership.
Skills/Requirements:
- Understand and implement operational strategic direction for clinical studies.
Location/Work:
- Armonk, NY; Warren, NJ; Uxbridge, UK; hybrid (4 days/week on site); up to 25% travel.
Benefits (as stated):
- Health/wellness programs, fitness centers, 401(k) match, equity awards, annual bonuses, paid time off, paid leaves.
Apply:
- Apply now to take your first step toward living the Regeneron Way.
- Accountable for global execution of assigned smaller/less complex clinical trials from study design through execution to close out; own study timelines and budget and ensure conduct per SOPs and ICH/GCP.
- Lead cross-functional study team and oversee delivery vs. timelines, deliverables, and budget; raise issues (conduct, quality, timelines, budget) and implement corrective actions.
- Provide operational input into protocol development; lead feasibility assessments; oversee/conduct site evaluation and selection; lead investigator meeting preparation and execution.
- Oversee/contribute to study documentation (e.g., CRFs, data management plan, monitoring plan/oversight plan, training plan, data review plan, statistical analysis plan).
- Oversee setup/maintenance of study systems (CTMS, TMF) and compliance with trial registry requirements.
- Identify outsourcing needs; lead vendor engagement, contracting, and management; ensure CRO/third parties deliver per scope.
- Lead study-level risk assessment/mitigation; monitor site activation/visits; oversee recruitment/retention strategies; monitor data entry and query resolution.
- Manage study close-out (database lock, vendor contract/budget/TMF reconciliation, drug accountability); contribute to CSR writing/review; facilitate lessons learned.
- Supervise CTM staff and assign tasks; recommend process improvements and continuous improvements to CTM SOPs.
Qualifications:
- Bachelor’s degree; 6+ years relevant industry experience.
- Extensive budget, vendor, and study team-building experience.
- Technical proficiency with trial management systems and Microsoft (Project, PowerPoint, Word, Excel); IVRS/IWRS and EDC.
- Global clinical trial operations experience; protocol/document development; strong ICH/GCP and regulatory knowledge; project management and cross-functional leadership.
Skills/Requirements:
- Understand and implement operational strategic direction for clinical studies.
Location/Work:
- Armonk, NY; Warren, NJ; Uxbridge, UK; hybrid (4 days/week on site); up to 25% travel.
Benefits (as stated):
- Health/wellness programs, fitness centers, 401(k) match, equity awards, annual bonuses, paid time off, paid leaves.
Apply:
- Apply now to take your first step toward living the Regeneron Way.