Senior Manager, Clinical Study Inspection Readiness, is tasked with spearheading clinical inspection readiness efforts to support the Program Operations Leader and Clinical Study Lead across one or more clinical programs within Clinical Trial Management.
Key responsibilities include leading the preparation and organization for GCP inspections in alignment with ICH/GCP guidelines, SOPs, Work Instructions, and Business Practice Tools.
This role involves providing inspection readiness leadership for both internally/outsourced studies working with CROs, serving as the point-of-contact for inspection readiness within CTM for stakeholders.
The position requires a minimum of three days onsite at either Westchester County NY OR Somerset County NJ with no option for remote work.
Key Responsibilities:
- Act as the primary CTM inspection readiness contact for internal and external teams.
- Collaborate with the Clinical Study Team and relevant functions to support CTM in responding to Inspection Management Q&A sessions and follow up on action items as needed.
- Support ongoing CTM activities, particularly TMF health and oversight.
- Provide guidance on compliance and regulatory matters, ensuring CTM study teams adhere to targeted SOPs, Business Practice Tools, and Working Instructions.
- Monitor and track inspection readiness meetings, action items, Q&A sessions, storyboards, and presentation requests with key stakeholders (internal/CRO) until resolution.
- Support CTM processes related to Inspection Readiness, ensuring that all necessary documentation is maintained in the TMF, including frequently requested documents and early identification of Sites of Interest (SOI).
- Work with Clinical Study Leads, CROs, and/or Vendor teams to obtain essential and regulatory documents for all studies/sites as part of Inspection Readiness activities.
- Track CTM action items following inspections, ensuring action plans are in place for remediation, with appropriate documentation and timelines for completion.
- Lead or participate in internal process improvement initiatives to enhance operational excellence in support of inspection readiness.
- The role may require up to 25% travel.
Qualifications:
- Bachelor’s degree with a minimum of 8 years of relevant industry experience.
- Experience with global agency inspections.
- Extensive knowledge in research & development with experience in global clinical trial operations, including protocol development and key study document preparation.
- Demonstrated interpersonal and leadership abilities, with a high degree of collaboration.
- Technical proficiency in trial management systems and MS applications (e.g., Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC).
