Senior Manager, Clinical Study Lead
Regeneron
9 hours ago
Remote friendly (Warren, NJ)
United States
Clinical Research and Development
Discover Your Role
- Leads the cross-functional study team responsible for clinical study delivery; primary leadership point of contact (as required)
- Oversees and contributes to study documentation development (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan, training plan, data review plan, statistical analysis plan)
- Oversees setup and maintenance of study systems (e.g., CTMS, TMF)
- Identifies outsourcing needs and leads engagement, contracting, and management of vendors
- Provides input into baseline budget and timeline development/management
- Leads risk assessment and develops risk mitigation strategies; leads feasibility assessment for regions/countries
- Monitors progress for site activation and monitoring visits; addresses deviations
- Leads patient recruitment/retention strategy development and implementation; monitors data entry/query resolution; addresses deviations
- Oversees drug/clinical supplies forecasting, drug accountability, and reconciliation
- Escalates study conduct, quality, timeline, or budget issues and implements corrective actions
- Manages study close-out (e.g., database lock, vendor contract/budget reconciliation, TMF, drug accountability)
- May perform unmasked tasks (e.g., unmasked TMF, review of unmasked data in EDC, IVRS issue contact, unmasked monitoring oversight)
- Directly supervises CTM staff (work assignments, performance management, recruitment, coaching/mentoring, training, compliance)
This Role Requires
- Bachelor’s degree and 8+ years relevant clinical trial experience
- Line management experience; exceptional interpersonal and leadership skills
- Proactive, self-disciplined; deadline driven; prioritization; ability to influence/negotiatate across stakeholders
- Advanced proficiency in trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC)
- Extensive global clinical trial operations experience; contributes to protocols and key study documents
Preferred/Additional
- Advanced expertise applying operational strategic direction for clinical studies
- Leads the cross-functional study team responsible for clinical study delivery; primary leadership point of contact (as required)
- Oversees and contributes to study documentation development (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan, training plan, data review plan, statistical analysis plan)
- Oversees setup and maintenance of study systems (e.g., CTMS, TMF)
- Identifies outsourcing needs and leads engagement, contracting, and management of vendors
- Provides input into baseline budget and timeline development/management
- Leads risk assessment and develops risk mitigation strategies; leads feasibility assessment for regions/countries
- Monitors progress for site activation and monitoring visits; addresses deviations
- Leads patient recruitment/retention strategy development and implementation; monitors data entry/query resolution; addresses deviations
- Oversees drug/clinical supplies forecasting, drug accountability, and reconciliation
- Escalates study conduct, quality, timeline, or budget issues and implements corrective actions
- Manages study close-out (e.g., database lock, vendor contract/budget reconciliation, TMF, drug accountability)
- May perform unmasked tasks (e.g., unmasked TMF, review of unmasked data in EDC, IVRS issue contact, unmasked monitoring oversight)
- Directly supervises CTM staff (work assignments, performance management, recruitment, coaching/mentoring, training, compliance)
This Role Requires
- Bachelor’s degree and 8+ years relevant clinical trial experience
- Line management experience; exceptional interpersonal and leadership skills
- Proactive, self-disciplined; deadline driven; prioritization; ability to influence/negotiatate across stakeholders
- Advanced proficiency in trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC)
- Extensive global clinical trial operations experience; contributes to protocols and key study documents
Preferred/Additional
- Advanced expertise applying operational strategic direction for clinical studies