Trial Master File Manager

Trial Master File Manager
  • Competitive
    HOUR
  • 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.

#LI-TR1

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

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