Senior Manager, Clinical Study Lead
Regeneron
September 02, 2026
Remote friendly (Armonk, NY)
United States
Clinical Research and Development
Role Responsibilities
- Accountable for global execution of assigned large/complex clinical trials from study design through close out; ensure timelines, budget, and conduct per Regeneron SOPs and ICH/GCP.
- Lead cross-functional study team delivery; primary leadership/oversight point of contact (as required).
- Oversee input to study-specific documents (e.g., CRFs, data management/monitoring plans, training plan, data review plan, statistical analysis plan).
- Oversee set-up/maintenance of study systems (e.g., CTMS, TMF).
- Identify outsourcing needs; lead engagement, contracting, and vendor management.
- Provide input into baseline budget and timeline development/management.
- Lead risk assessment and study-level mitigation strategies; lead feasibility assessment for regions/countries.
- Monitor site activation and monitoring visits; act on deviations.
- Lead patient recruitment/retention strategy development/implementation; monitor data entry/query resolution and act on deviations.
- Oversee input to drug/clinical supplies forecasting, drug accountability, and reconciliation.
- Escalate issues (conduct/quality/timelines/budget) and implement corrective actions.
- Manage/oversee study close-out (database lock, vendor contract reconciliation, budget, TMF, drug accountability).
- May handle unmasked study tasks (as assigned).
- Directly supervise CTM staff; line management and compliance, training, coaching/mentoring.
Qualifications/Requirements
- Bachelor’s degree; minimum 8 years relevant clinical trial experience.
- Experience with line management; exceptional interpersonal and leadership skills.
- Proactive, deadline-driven, strong prioritization; ability to influence/negotiation across stakeholders.
- Advanced proficiency: trial management systems and MS (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC).
- Extensive global clinical trial operations experience; contributes to protocols and key documents.
Application
- Apply now.
- Accountable for global execution of assigned large/complex clinical trials from study design through close out; ensure timelines, budget, and conduct per Regeneron SOPs and ICH/GCP.
- Lead cross-functional study team delivery; primary leadership/oversight point of contact (as required).
- Oversee input to study-specific documents (e.g., CRFs, data management/monitoring plans, training plan, data review plan, statistical analysis plan).
- Oversee set-up/maintenance of study systems (e.g., CTMS, TMF).
- Identify outsourcing needs; lead engagement, contracting, and vendor management.
- Provide input into baseline budget and timeline development/management.
- Lead risk assessment and study-level mitigation strategies; lead feasibility assessment for regions/countries.
- Monitor site activation and monitoring visits; act on deviations.
- Lead patient recruitment/retention strategy development/implementation; monitor data entry/query resolution and act on deviations.
- Oversee input to drug/clinical supplies forecasting, drug accountability, and reconciliation.
- Escalate issues (conduct/quality/timelines/budget) and implement corrective actions.
- Manage/oversee study close-out (database lock, vendor contract reconciliation, budget, TMF, drug accountability).
- May handle unmasked study tasks (as assigned).
- Directly supervise CTM staff; line management and compliance, training, coaching/mentoring.
Qualifications/Requirements
- Bachelor’s degree; minimum 8 years relevant clinical trial experience.
- Experience with line management; exceptional interpersonal and leadership skills.
- Proactive, deadline-driven, strong prioritization; ability to influence/negotiation across stakeholders.
- Advanced proficiency: trial management systems and MS (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC).
- Extensive global clinical trial operations experience; contributes to protocols and key documents.
Application
- Apply now.