Sr. Mgr Clinical Study Inspection Readiness

The Sr. Mgr., Clinical Study Inspection Readiness, is responsible for leading clinical inspection readiness activities to support the Program Operations Leader and Clinical Study Lead(s) for one or more assigned clinical programs within Clinical Trial Management.  The role is responsible for leadership, preparation, and organization for GCP inspections in accordance with ICH/GCP, Regeneron Standard Operating Procedures (SOPs), Work Instructions (WI) and Business Practice Tools (BPT).  This role will provide inspection readiness leadership to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and serves as the key CTM inspection readiness point person for internal/external team members.  This role interacts closely with the GCP Quality and Inspection Management groups.

A typical day in this role looks like:  

• Support the Program Operations Leader and Clinical Study Lead(s) in focused leadership, preparation, and organization for GCP inspections with a focus on clinical trial management activities for assigned programs and trials
• Serve as a key point of contact for CTM inspection readiness activities and point person for internal/external team members.
• Interacts closely with the GCP Quality, Development Records Management (DRM) and Inspection Management groups to ensure key CTM actions and deliverables are tracked
• Work with 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.
• Lead weekly/biweekly inspection preparation meetings with CTM with a focus on Inspection Preparation at the Study Level (readiness/completeness of the CTM inspection readiness tracker, Suspected Non-Compliance reports, Storyboards, TMF Health metrics etc.) and Site Level (overall site level quality conduct such as monitoring frequency, EDC data entry, query resolutions, etc.) 
• Provide periodic, executive summary updates to CTM Senior Leadership (e.g. Therapeutic Operations Leader, Heads CTM) on status of inspection readiness, risks, and mitigations
• Support ongoing CTM activities related to TMF health and oversight
• Conduct review and analysis of ongoing Essential Document metrics and quality reports on an ongoing basis to support CTM in managing TMF compliance and action, as needed with CST members
• Track and ensure positive Financial Disclosures are reviewed by Regeneron’s Compliance Committee.  Support collection and tracking of study Financial Disclosure Forms for applicable Significant Payments of Other Sorts (SPOOS) tracking to support BLA submissions.
• Provide guidance on compliance and regulations and ensure CTM staff study teams are following targeted SOPs during study, Business Practice Tools and Working Instructions 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
• Support the CTM processes related to Inspection Readiness to ensure that appropriate documentation is produced/maintained in the TMF, including frequently requested documents and early identification of Sites of Interest (SOI).
• Work with internal study team and/or CRO to ensure our key Site of Interest (SOI) sites are prepared for potential audits (study files complete, open actions closed out, all deviations reported, etc). Assist with follow up of any action items from the REGN visits as part of the inspection readiness activities.
• 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 with DRM. 
• Support the collection and review of CTM led staging room documents and pre-requested documents in preparation for mock/actual inspections.  This includes but not limited to essential/regulatory documents and  all protocols, plans, manuals to support the inspection.  Triaging these type of Inspection requests to CTM team members until completion. 
• Attend the mock and actual inspection and act as a project manager during the inspection process and assist the CTM team with follow up requests from the inspector/inspection management team  In presence attendance during all inspections is required unless otherwise indicated by Senior Leadership.
• 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
• Ensure that significant CTM related findings that impact process changes/improvements are discussed with TA and Program Ope