Senior Manager, Clinical Study Lead (Genetics Medicine, Hepatology)
Regeneron
3 months ago
On-site
Cambridge, MA
Clinical Research and Development
Responsibilities
- Accountable for global execution of assigned large/complex clinical trials from study design through close-out.
- Ensure study conduct complies with Regeneron SOPs and ICH/GCP; manage study timelines and budget.
- Lead cross-functional study team and serve as primary leadership/oversight point of contact.
- Provide operational input into protocol development.
- Oversee development of study documents (e.g., CRFs, data management plan, monitoring plan, training plan, data review plan, statistical analysis plan).
- Oversee setup/maintenance of study systems (e.g., CTMS, TMF).
- Ensure compliance with clinical trial registry requirements.
- Identify outsourcing needs; lead vendor engagement, contracting, and management.
- Provide input into baseline budget and timeline development/management.
- Lead study-level risk assessment and define mitigation strategies.
- Lead feasibility assessment for regions/countries; oversee site evaluation and selection.
- Prepare and execute investigator meetings.
- Monitor site activation and monitoring visits; manage deviations.
- Lead patient recruitment/retention strategy development and implementation.
- Monitor data entry and query resolution; manage deviations.
- Ensure accurate budget management and scope changes; oversee drug/supplies forecasting, drug accountability, and reconciliation.
- Escalate issues related to conduct, quality, timelines, or budget; develop/implement corrective actions.
- Oversee execution against deliverables/timelines/budget; oversee data quality (metrics, listings, deviations, eligibility/dosing issues, suspected serious non-compliance).
- Ensure CROs/third-party vendors deliver per scope of work.
- Maintain audit/inspection readiness; support audits/inspections and contribute to CAPAs.
- Manage study close-out (database lock; reconciliation of contracts, budget, TMF, and drug accountability).
- Contribute to clinical study report writing/review; facilitate lessons learned.
- Assign tasks to Clinical Study Management staff and support deliverables.
- Recommend/participate in process improvement initiatives and CTM SOP continuous improvement.
- May handle unmasked study tasks (e.g., IVRS issues, unmasked TMF/data, oversight of unmasked monitoring).
- Directly supervise CTM staff (line management, performance, recruiting, development, coaching, training, compliance).
- May require ~25% travel.
Qualifications / Skills
- Bachelor’s degree required.
- Minimum 8 years relevant clinical trial experience.
- Advanced expertise in clinical trial operations and operational strategic execution.
- Strong interpersonal/leadership, communication, and presentation skills.
- Data-driven planning/execution/problem solving; proactive, deadline-driven.
- Ability to influence/negotiates across stakeholders.
- Strong budget management.
- Ability to build/lead/develop study teams and collaborations.
- Advanced negotiation skills for vendor management.
- Technical proficiency in trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC).
- Extensive global clinical trial operations experience.
- Knowledge of ICH/GCP and regulatory guidelines/directives.
- Advanced project management; cross-functional leadership and organizational skills.
- Line management experience.
Application instructions
- Apply now.
- Accountable for global execution of assigned large/complex clinical trials from study design through close-out.
- Ensure study conduct complies with Regeneron SOPs and ICH/GCP; manage study timelines and budget.
- Lead cross-functional study team and serve as primary leadership/oversight point of contact.
- Provide operational input into protocol development.
- Oversee development of study documents (e.g., CRFs, data management plan, monitoring plan, training plan, data review plan, statistical analysis plan).
- Oversee setup/maintenance of study systems (e.g., CTMS, TMF).
- Ensure compliance with clinical trial registry requirements.
- Identify outsourcing needs; lead vendor engagement, contracting, and management.
- Provide input into baseline budget and timeline development/management.
- Lead study-level risk assessment and define mitigation strategies.
- Lead feasibility assessment for regions/countries; oversee site evaluation and selection.
- Prepare and execute investigator meetings.
- Monitor site activation and monitoring visits; manage deviations.
- Lead patient recruitment/retention strategy development and implementation.
- Monitor data entry and query resolution; manage deviations.
- Ensure accurate budget management and scope changes; oversee drug/supplies forecasting, drug accountability, and reconciliation.
- Escalate issues related to conduct, quality, timelines, or budget; develop/implement corrective actions.
- Oversee execution against deliverables/timelines/budget; oversee data quality (metrics, listings, deviations, eligibility/dosing issues, suspected serious non-compliance).
- Ensure CROs/third-party vendors deliver per scope of work.
- Maintain audit/inspection readiness; support audits/inspections and contribute to CAPAs.
- Manage study close-out (database lock; reconciliation of contracts, budget, TMF, and drug accountability).
- Contribute to clinical study report writing/review; facilitate lessons learned.
- Assign tasks to Clinical Study Management staff and support deliverables.
- Recommend/participate in process improvement initiatives and CTM SOP continuous improvement.
- May handle unmasked study tasks (e.g., IVRS issues, unmasked TMF/data, oversight of unmasked monitoring).
- Directly supervise CTM staff (line management, performance, recruiting, development, coaching, training, compliance).
- May require ~25% travel.
Qualifications / Skills
- Bachelor’s degree required.
- Minimum 8 years relevant clinical trial experience.
- Advanced expertise in clinical trial operations and operational strategic execution.
- Strong interpersonal/leadership, communication, and presentation skills.
- Data-driven planning/execution/problem solving; proactive, deadline-driven.
- Ability to influence/negotiates across stakeholders.
- Strong budget management.
- Ability to build/lead/develop study teams and collaborations.
- Advanced negotiation skills for vendor management.
- Technical proficiency in trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC).
- Extensive global clinical trial operations experience.
- Knowledge of ICH/GCP and regulatory guidelines/directives.
- Advanced project management; cross-functional leadership and organizational skills.
- Line management experience.
Application instructions
- Apply now.