Biotech/Pharmaceutical

Trial Master File Manager III

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

Job Description:

Duties: TMF Quality

  • Create and manage Study TMF Filing plan with input from Study team
  • Provide day to day document management support
  • Support TMF review process by working closely with study teams, CROs and Vendors
  • Ensure Study EDLs and Milestones are configured and maintained
  • Perform and manage TMF Quality reviews and drive for constant inspection readiness of TMFs
  • Serve as point of contact and support study teams for resolution of TMF-related queries or quality issues
  • Act as point of contact to support TMF audits and inspections as required

Process Improvement and Training

  • Support and/or deliver training across company, CRO and Vendors on the policies and procedures relative to and for TMF management
  • Foster positive relationships with external vendors and internal clinical development areas

eTMF Administration

  • Act as Subject Matter Expert for eTMF management
  • Oversee the management of askTMF mailbox and FAQ log

Qualifications:

  • Bachelor’s Degree or relevant demonstrable related pharmaceutical / biotechnology industry experience including records management in a GCP-regulated environment
  • 6-9 years as TMF manager with prior Veeva eTMF Specialist experience
  • Strong working knowledge of the TMF Reference Model
  • Strong knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to TMF
  • Experience of electronic document management system(s) and Veeva eTMF REQUIRED
  • Working knowledge of Regulatory Agency Audits and NDA/MAA Submission triggered Inspections preferred
  • Strong interpersonal skills and ability to manage at all levels within a cross-functional organization through influence
  • Continuous improvement mindset and ability to function independently with a proactive, self-starter attitude
  • Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.
  • Ability to handle a high volume of complex tasks within a given timeline

 

 

 

Tagged as: Trial Master File Manager III