Senior Manager/Manager, Trial Master File - NC Pharma - Homebased

Job Type: 
Life Sciences
Data Management, Biostatistics and Programming
Other Life Science Positions
Employment Category: 
Direct Hire

Our client, a NC-based biopharmaceutical firm with a focus in the oncology space, is actively recruiting for a highly organized, detail oriented, knowledgeable and collaborative Senior Manager to lead its Trial Master File (TMF) function on its Clinical Operations team.

 

The client is targeting NC-based candidates who can go into the office a few times a month as needed.  This is a priority role and the Company will pay generously to attract and retain a star.

 

This company is developing multiple products to treat cancer and other serious illnesses. The TMF Manager serves as the subject matter expert and primary point of contact for activities associated with ensuring the TMF meets the expectations of Health Authorities and Regulatory Agencies from a compliance and archival perspective. 

 

Primarily activities include:

  • Supporting the Clinical Trial Manager (CTM) with the creation of the TMF Plan
  • Closure and archival of TMF’s
  • Ensuring TMF inspection readiness through the oversight of the TMF Team (2-4 Specialists) and maintenance of the Clinical File Room

 

This is a highly collaborative role. We seek a candidate with superb communication, collaboration, and leadership skills to drive the TMF function.

 

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
  • Continually reviews the Trial Master File (TMF) in cooperation with CTMs to ensure a current inspection readiness state
  • 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
  • Responsible for archiving of assigned TMFs, including those transferred from CRO partners
  • Serves as the TMF point of contact for inspections and audits.
  • Escalates TMF quality issues and inspection readiness concerns to the CTMs and Clinical Operations leadership.
  • Ensure TMF procedures reflect current industry standards and guidance.
  • Serves as Application Manager for the hosted eTMF.
  • Serves as the Application Manager for the CTMS.
  • Supervises TMF specialists, provides ongoing support and coaching.

 

The right candidate will offer a degree in in a related discipline and 5+ years of experience working in Clinical Development with the TMF.    Solid knowledge and understanding of the TMF related components of inspection readiness.

 

Other priorities include:

  • Demonstrated ability to manage the TMF
  • Background in partnering with clinical operations teams
  • Experience overseeing 3rd party partners involved in the process
  • Thorough knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and Food and Drug Administration (FDA) and/or EU guidelines
  • Solid knowledge and understanding of the TMF related components of inspection readiness.

 

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