Senior Manager, Clinical Study Inspection Readiness

Senior Manager, Clinical Study Inspection Readiness

Discover Your Role
- Lead GCP inspection readiness programs across complex, multi-program portfolios (internal teams, CRO partners, Inspection Management)
- Own the inspection process end-to-end (mock, dry run, actual), managing inspector/inspection management follow-ups
- Partner with Clinical Study Teams to prepare Q&A responses and drive action items to closure
- Guide CTM staff on compliance with SOPs, Business Practice Tools, and Work Instructions throughout the study lifecycle
- Track inspection readiness meetings, action items, storyboards, and presentation requests through resolution
- Manage the full inspection action item lifecycle (pre-readiness through post-inspection remediation, timelines, and closure) with complete audit trail
- Champion AI-powered tools to accelerate deliverables (executive summaries, storyboards, CAPA narratives, TMF gap analyses)
- Coach, develop, and set goals for direct reports; review performance against quality and timeliness standards

This Role Requires
- BS/BA degree and 8+ years relevant clinical experience
- Strong project management skills under live inspection timelines
- Preferred: hands-on clinical inspection experience (mock/dry run/actual)
- Preferred: experience partnering with CROs and cross-functional clinical study teams
- Preferred: familiarity with AI productivity tools (e.g., Claude, Microsoft Copilot) in documentation/compliance
- Proactive risk thinking (identify Sites of Interest and documentation gaps)
- Clear communication with internal teams, CRO partners, and inspectors
- Ability to lead/coaching while staying hands-on

Application Instructions
- Apply now.

Location/Travel
- Armonk, NY; Warren, NJ. Travel up to 25%.

Salary Range (annually)
- $150,500.00 - $245,500.00