Senior Manager Clinical Study Inspection Readiness

About the role

The Senior Manager, Clinical Study Inspection Readiness leads all Good Clinical Practice (GCP) inspection readiness activities for one or more assigned clinical programs within Clinical Trial Management (CTM). Reporting to senior leadership and partnering closely with Program Operations Leaders (POLs) and Clinical Study Leads (CSLs), this role owns the preparation, organization, and execution of inspection readiness strategy in accordance with International Council for Harmonization (ICH)/GCP guidelines, Regeneron Standard Operating Procedures (SOPs), Work Instructions (WIs), and Business Practice Tools (BPTs).

Responsibilities

• CTM Inspection Readiness point of contact leading GCP inspection readiness programs across complex, multi-program clinical portfolios involving both internal teams including CRO partners, and Inspection Management.
• Project manager during the inspection process (mock, dry run and/or actual).
• Assist, and/or lead (as needed) the CTM team with follow up requests from the inspector/inspection management team during mock and actual inspection(s).
• Provide guidance and support to Clinical Trial Management as follows:
• Support the Clinical Study Team (CST) and functional areas to support CTM in providing responses to the Q&A sessions held by Inspection Management for Inspection Readiness, support action item follow up as needed.
• Support ongoing CTM activities related to TMF health and oversight.
• Ensure compliance and regulations are followed and CTM staff study teams are following targeted SOPs, BPTs, and WIs during the study.
• Track inspection readiness meetings, CTM Inspection action items, questions and answers, storyboards, and presentation requests with key stakeholders (internal/CRO) until closure.
• Manage CTM inspection action items throughout the inspection lifecycle, from pre-inspection activities (readiness meetings, Q&As, storyboards, presentation requests with internal/CRO stakeholders) to post-inspection tasks (remediation plans, timelines, documentation, closure updates), ensuring prompt resolution and a complete audit trail.
• Work with the Clinical Study Leads, CRO and/or Vendor team(s) to obtain all the necessary essential and regulatory documents for all study/sites as part of the IRR activities.
• Track CTM action items assigned following inspections to ensure action plans are in place for remediation, as needed, with timelines for completion. Ensure supportive documentation is available to support resolution of the action items and provides updates to as needed on the resolution.
• Lead and participate in internal process improvement projects/initiatives to continuously improve operational excellence to support inspection readiness.
• Utilize AI-powered applications (e.g., Claude, Microsoft Copilot) to draft, refine, and quality-check executive summaries, inspection storyboards, response documents, and Corrective and Preventive Action (CAPA) narratives, TMF gap analysis, action item tracking, and executive communication.

Qualifications

• A minimum of a BS/BA Degree and 8+ years relevant clinical experience.
• Clinical Inspection experience heavily preferred.