Senior Manager Clinical Study Inspection Readiness
Core
Leads GCP inspection readiness strategy and execution for clinical programs, managing preparation, organization, and response to regulatory inspections for both internal studies and CROs.
Role type
Senior Manager, Clinical Operations
Builds
Inspection readiness programs and audit trails for clinical trial management
Domain
Clinical Trials / Regulatory Compliance
Deliverable
client delivery
Required skills
GCP compliance, inspection readiness strategy, project management, stakeholder management, action item tracking, TMF oversight, regulatory guidance, team leadership, AI tool utilization
Preferred skills
Clinical inspection experience
Technologies
Claude, Microsoft Copilot
Responsibilities
Lead GCP inspection readiness programs across multi-program clinical portfolios; manage CTM inspection action items from pre-inspection to post-inspection remediation; support Q&A sessions and response documentation for inspection management; oversee TMF health and ensure SOP compliance; coach and manage direct reports; utilize AI tools to draft executive summaries and CAPA narratives.
Seniority
Senior, hands-on IC with management responsibilities
