Specialist, Document & Clinical Systems (TMF)

About the role

Provides support to Clinical Operations (CO) Study Teams by creating plans for the quality, compliance and inspection-readiness of all Neurocrine trial master files (TMF). May serve as subject matter expert for electronic TMF (eTMF) end-users, and facilitates responses to audits/inspections.

Collaborates closely with the Clinical Operations Study Team Members and Functional Groups as TMF System Owner.

Your Contributions

• In collaboration with the CO Study Team, Vendors, Functional Group Representatives and other Stakeholders to assist in the set-up, review, maintenance and archival of study specific TMFs according to applicable regulations and industry standards
• Aid in documenting the set-up, review, maintenance and archival of study specific TMFs in TMF Plans and study specific TMF Index
• Plans may include TMF transition and/or migration activities
• Provide guidance for the eTMF, providing technical expertise and advice to end-users and all stakeholders
• Take a proactive role in providing a high level of service to eTMF end-users
• Prepare for and participate in internal or external audits/inspections including providing audit/inspection responses and facilitating inspector access to TMFs, as required
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Develops and maintains close working relationships with other functional areas outside of Clinical Operations e.g. Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, Vendors etc. to facilitate TMF development
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Develops and maintains close working relationships with other functional areas outside of Clinical Operations e.g. Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, Vendors etc. to facilitate TMF development
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team Meetings and eTMF QC Meetings, as requested
• Supports quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and