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Clinical Trial Inspection Readiness Senior Manager

2 months ago

New York, New York, United States Cpl Life Sciences US Full time

The Senior Manager of Clinical Study Inspection Preparedness is responsible for leading initiatives to ensure readiness for clinical inspections, supporting the Program Operations Leader and Clinical Study Lead across various clinical programs within Clinical Trial Management.

This role involves overseeing the preparation and organization for GCP inspections, ensuring compliance with ICH/GCP guidelines, SOPs, Work Instructions, and Business Practice Tools.

The position requires providing leadership in inspection readiness for both internal and outsourced studies, collaborating closely with CROs, and serving as the primary contact for stakeholders regarding inspection readiness.

Key Responsibilities:

  • Serve as the main point of contact for inspection readiness within CTM for both internal and external teams.
  • Work alongside the Clinical Study Team and relevant departments to assist CTM in addressing Inspection Management Q&A sessions and follow up on necessary action items.
  • Support ongoing CTM operations, with a focus on TMF health and oversight.
  • Provide expert guidance on compliance and regulatory issues, ensuring adherence to established SOPs, Business Practice Tools, and Working Instructions.
  • Track and monitor inspection readiness meetings, action items, Q&A sessions, storyboards, and presentation requests with key stakeholders until resolution.
  • Facilitate CTM processes related to Inspection Readiness, ensuring that all required documentation is accurately maintained in the TMF, including frequently requested documents and early identification of Sites of Interest (SOI).
  • Collaborate with Clinical Study Leads, CROs, and/or Vendor teams to secure essential regulatory documents for all studies/sites as part of Inspection Readiness efforts.
  • Oversee CTM action items post-inspections, ensuring that remediation action plans are established with appropriate documentation and timelines for completion.
  • Lead or engage in internal process improvement initiatives aimed at enhancing operational excellence in support of inspection readiness.
  • This role may involve up to 25% travel.

Qualifications:

  • A Bachelor's degree with a minimum of 8 years of relevant industry experience.
  • Experience with global agency inspections.
  • In-depth knowledge of research and development, with experience in global clinical trial operations, including protocol development and key study document preparation.
  • Proven interpersonal and leadership skills, demonstrating a high level of collaboration.
  • Technical proficiency in trial management systems and MS applications (e.g., Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC).