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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 plays a pivotal role in leading initiatives aimed at ensuring readiness for clinical inspections, collaborating closely with the Program Operations Leader and Clinical Study Lead across various clinical programs within Clinical Trial Management.

Key responsibilities encompass overseeing the preparation and coordination for GCP inspections, ensuring compliance with ICH/GCP guidelines, standard operating procedures, work instructions, and business practice tools.

This position is crucial in providing 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 inspection readiness within Clinical Trial Management for all stakeholders.

The role necessitates a minimum of three days onsite at designated locations, with no remote work options available.

Key Responsibilities:

  • Serve as the main 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 action items as required.
  • Support ongoing Clinical Trial Management activities, particularly focusing on Trial Master File (TMF) health and oversight.
  • Provide expert guidance on compliance and regulatory issues, ensuring adherence to established SOPs, business practice tools, and working instructions by study teams.
  • Monitor and manage inspection readiness meetings, action items, Q&A sessions, storyboards, and presentation requests with key stakeholders until resolution.
  • Facilitate Clinical Trial Management processes related to Inspection Readiness, ensuring that all necessary documentation is preserved 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.
  • Track action items following inspections, ensuring that remediation action plans are documented and timelines for completion are established.
  • Lead or engage in internal process improvement initiatives aimed at enhancing operational excellence in support of inspection readiness.
  • This role may require up to 25% travel.

Qualifications:

  • A Bachelor's degree accompanied by a minimum of 8 years of relevant industry experience.
  • Proven experience with global agency inspections.
  • Extensive knowledge in research and development, particularly in global clinical trial operations, including protocol development and preparation of key study documents.
  • Demonstrated interpersonal and leadership 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).