(Sr) Manager, Trial Master File (TMF) - NC Pharma/Hybrid (Direct Hire)

Our client, an RTP-area Biopharmaceutical company with products in the oncology and severe disease space, is actively recruiting for a highly skilled, knowledgeable and collaborative Trial Master File Manager or Senior Manager to join its Clinical Development Team.

 This TMF Manager will lead a team of 3.  They will serve as the subject matter expert and primary point of contact for activities associated with ensuring the Trial Master Files (TMFs) are in compliance with Company and Health Authorities/Regulatory Agencies guidelines and standards.

The client is targeting a NC-based candidate who can work Hybrid. This is a priority role and the Company will pay generous wage to attract and retain a star.

 Role will involve supporting the Clinical Trial Manager with the creation of the TMF Plan, as well as closure and archival of TMFs and ensuring TMF inspection readiness through the oversight of the TMF Team/Specialists.

 Specific responsibilities will include:

• Serves as a subject matter expert for TMF compliance and archival related activities.
• Ensures completeness, quality, and inspection readiness of the TMFs.
• Works with the Clinical Trial Managers to create TMF Plans with associated timelines.
• Assigns study responsibilities to the TMF Team. Ensures TMF Lead has appropriate oversight responsibilities.
• Supports Company teams in all types of trials (ClinPharm, Sponsored, and IIT) and all trial phases (start-up, maintenance, and closure) via the TMF Team.
• Ensures there are reviews of the Trial Master File (TMF) in cooperation with CTMs on a periodic basis always ensuring a current state.
• Monitors TMFs metrics to ensure compliance with TMF filing across all studies.
• Ensures a final TMF review meeting occurs between TMF Team and CTMs to ensure all activities are executed prior to the TMF being considered complete.
• Serves as the TMF point of contact for inspections and audits.
• Ensures TMF procedures reflect current industry standards and guidance.
• Oversees training development of eTMF and CTMS systems.
• Serves as Application Manager for the hosted eTMF and the CTMS.

 The right candidate will offer a bachelor’s degree or relevant experience in a health related discipline and 5+ years of TMF Management experience in a clinical development setting. Strong preference for candidates who are coming from a pharma/sponsor company.

 Other priorities include:

• Understanding of the TMF related components of inspection readiness
• Line management experience, this role will be leading a team of 3.
• Experience partnering with cross fuctional teams and 3^rd party partners involved in the process
• Thorough knowledge of clinical research, clinical development and industry standards
• Working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and Food and Drug Administration (FDA) and/or EU guidelines.

 This is an exciting company at an exciting time. Please forward Word resume for prompt consideration.