Trial Master File Manager (TMF) - new job in Cambridge, US

Trial Master File Manager (TMF)
  • Competitive
    HOUR
  • Temporary
  • Cambridge MA, US Cambridge MIDDLESEX US 02142
Job Ref: JO000133111
Sector: Clinical
Sub-sector: Clinical
Date Added: 21 September 2022

Trial Master File Manager

SRG is looking for an agile, self-motivated, and experienced individual to be responsible for working across clinical study teams to design and implement eTMF strategy, governance, and processes, and review/conduct quality checks of eTMFs and TMF documentation across the portfolio. This role will also manage filing and maintenance activities for clinical trials during the study start-up, maintenance and close-out periods. The successful candidate will be detail-oriented with a flexible and solution-oriented outlook with the ability to support team members and our CRO partners.

Here’s What You’ll Do:

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 on the policies and procedures relative to and for TMF management
  • Foster positive relationships with external vendors and internal clinical development areas

Here’s What You’ll Bring to the Table:

  • 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

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

#IND-P1

SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/website-logo-all-padding-removed.png
30/09/2022 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Tyler Rostad

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