Senior Manager Clinical Study Inspection Readiness
Regeneron
15 days ago
On-site
Armonk, NY
Clinical Research and Development
Senior Manager, Clinical Study Inspection Readiness
Responsibilities
- Lead GCP inspection readiness activities for one or more clinical programs within Clinical Trial Management (CTM); serve as primary CTM point of contact for all inspection-related activities.
- Own preparation, organization, and execution of inspection readiness strategy per ICH/GCP, Regeneron SOPs, Work Instructions (WIs), and Business Practice Tools (BPTs) across internal and CRO/outsourced studies.
- Lead mock/dry run/actual inspection project management; assist/lead CTM team with inspector/Inspection Management follow-up requests.
- Support CTM responses to Inspection Management Q&As; manage action item follow-up to closure with complete audit trail.
- Support TMF health and oversight; ensure appropriate inspection documentation is produced/maintained in TMF, including frequently requested documents and early identification of Sites of Interest (SOI).
- Track inspection readiness meetings, Q&As, storyboards, and presentation requests; manage action items pre- and post-inspection (remediation plans, timelines, closure updates).
- Obtain essential and regulatory documents for studies/sites with Clinical Study Leads and CRO/vendor teams.
- May lead internal process improvement initiatives to enhance inspection readiness.
- Use AI-powered tools (e.g., Claude, Microsoft Copilot) for drafting/refining/quality-checking executive summaries, storyboards, response documents, CAPA narratives, TMF gap analysis, action item tracking, and executive communication (human reviewed; GCP compliant).
- Establish goals/accountabilities, review performance for quality/timeliness, coach/manage/training for direct reports.
- May require up to 25% travel.
Qualifications
- BS/BA degree.
- 8+ years relevant clinical experience.
- Clinical inspection experience heavily preferred.
Application
- Apply now.
Responsibilities
- Lead GCP inspection readiness activities for one or more clinical programs within Clinical Trial Management (CTM); serve as primary CTM point of contact for all inspection-related activities.
- Own preparation, organization, and execution of inspection readiness strategy per ICH/GCP, Regeneron SOPs, Work Instructions (WIs), and Business Practice Tools (BPTs) across internal and CRO/outsourced studies.
- Lead mock/dry run/actual inspection project management; assist/lead CTM team with inspector/Inspection Management follow-up requests.
- Support CTM responses to Inspection Management Q&As; manage action item follow-up to closure with complete audit trail.
- Support TMF health and oversight; ensure appropriate inspection documentation is produced/maintained in TMF, including frequently requested documents and early identification of Sites of Interest (SOI).
- Track inspection readiness meetings, Q&As, storyboards, and presentation requests; manage action items pre- and post-inspection (remediation plans, timelines, closure updates).
- Obtain essential and regulatory documents for studies/sites with Clinical Study Leads and CRO/vendor teams.
- May lead internal process improvement initiatives to enhance inspection readiness.
- Use AI-powered tools (e.g., Claude, Microsoft Copilot) for drafting/refining/quality-checking executive summaries, storyboards, response documents, CAPA narratives, TMF gap analysis, action item tracking, and executive communication (human reviewed; GCP compliant).
- Establish goals/accountabilities, review performance for quality/timeliness, coach/manage/training for direct reports.
- May require up to 25% travel.
Qualifications
- BS/BA degree.
- 8+ years relevant clinical experience.
- Clinical inspection experience heavily preferred.
Application
- Apply now.