Trial Master File Manager

Trial Master File Manager
  • Competitive
  • Temporary
  • Cambridge MA, US Cambridge MIDDLESEX US 02142
Job Ref: JO000126522
Sector: Clinical
Sub-sector: Clinical
Date Added: 13 December 2021

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:

eTMF Administration

  • Support eTMF Business Administrator for user account management, create and promote studies in the eTMF, and unblinding
  • Act as Subject Matter Expert for eTMF management
  • Ensure suitable reports and outputs are built to support TMF Quality
  • Oversee the management of askTMF mailbox and FAQ log

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

Paper TMF

  • Oversee the Set-up of TMF paper folders and management of inventory trackers
  • Ensure the CRO’s portion of the TMF is processed in a timely and controlled manner
  • Support the management and tracking of TMF records received, filed, archived, retrieved, transferred and destroyed in compliance with company policies

TMF Archiving

  • Oversee the preparation of TMF records (paper and electronic) for long-term, off-site archival in compliance with company procedures, GCP and other relevant global regulatory requirements
  • Oversee the quality checks and retrievals testing of TMF records from long-term archival
  • Participate in independent audits of external archive facilities, as applicable

Process Improvement and Training

  • Author, contribute to, maintain and implement TMF Management Controlled Documents and associated resources (e.g. training materials, knowledge databases)
  • 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
  • Work with Strategic CRO Partners on the continued development of TMF and Record Management practices and expectations

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 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 preferred
  • 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.


29/01/2022 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Tyler Rostad

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