Clinical Trial Inspection Readiness Senior Manager

1 week 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 efforts to ensure readiness for clinical inspections, collaborating closely with the Program Operations Leader and Clinical Study Lead across various clinical programs within Clinical Trial Management.

This role encompasses overseeing the preparation and organization for GCP inspections, ensuring compliance with ICH/GCP guidelines, standard operating procedures (SOPs), work instructions, and business practice tools.

The position provides leadership in inspection readiness for both internal and outsourced studies, working in partnership with Contract Research Organizations (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 Clinical Trial Management for both internal and external teams.
  • Collaborate with the Clinical Study Team and relevant departments to assist in responding to Inspection Management Q&A sessions and ensure follow-up on necessary action items.
  • Support ongoing activities within Clinical Trial Management, particularly focusing on Trial Master File (TMF) health and oversight.
  • Provide expert guidance on compliance and regulatory issues, ensuring adherence to targeted SOPs, business practice tools, and working instructions.
  • Monitor and manage inspection readiness meetings, tracking action items, Q&A sessions, storyboards, and presentation requests with key stakeholders until resolution.
  • Ensure that all required documentation is maintained in the TMF, including frequently requested documents and early identification of Sites of Interest (SOI).
  • Collaborate with Clinical Study Leads, CROs, and vendor teams to acquire essential regulatory documents for all studies/sites as part of inspection readiness activities.
  • Track action items post-inspection, ensuring that remediation action plans are established with appropriate documentation and timelines for completion.
  • Lead or participate in initiatives aimed at improving internal processes to enhance operational excellence in support of inspection readiness.
  • The role may involve up to 25% travel.

Qualifications:

  • A Bachelor’s degree with a minimum of 8 years of relevant industry experience.
  • Proven experience with global agency inspections.
  • Extensive knowledge in research and development, with experience in global clinical trial operations, including protocol development and preparation of key study documents.
  • Demonstrated leadership and interpersonal skills, with a strong emphasis on collaboration.
  • Technical proficiency in trial management systems and Microsoft applications (e.g., Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC).


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