TMF Lead II

Premier Research

10d

About The Position

Premier Research is seeking a TMF Lead II for its Pharmacovigilance and Records Management team. The role manages electronic and/or paper Trial Master File (TMF) records according to Company, Sponsor, industry, ICH-GCP, and global regulatory standards. The TMF Lead oversees TMF setup, maintenance, and closure, including developing and maintaining study TMF Plans and indexes. The role may also handle TMF transitions and work with Sponsor TMF processes and systems. The TMF Lead provides oversight, training, KPI analysis, and status reporting to support compliance by Premier project teams, Sponsors, and third parties with applicable TMF SOPs, plans, and transition plans. The role takes initiative to identify and address quality and completeness deficiencies that could affect audit or inspection readiness or the delivery of high-quality TMFs.

Requirements

Minimum of a high school diploma or international equivalent.
At least 8 years of eTMF systems experience.
At least 8 years of Trial Master File management experience.
At least 8 years of TMF Reference Model experience.
At least 2 years of TMF Lead experience.
Knowledge of ICH-GCP, ISO 14155, FDA CFR Part 11, and global regulations related to the investigational drug and device industry.

Nice To Haves

Undergraduate degree from an accredited institution, preferably in records and information management, library science, clinical, science, or a health-related field.
Equivalent clinical trials records management experience may be considered in place of the preferred undergraduate degree.

Responsibilities

Act as the primary TMF point of contact for project teams, Sponsors, auditors, and other third parties on assigned studies.
Work directly with records specialists assigned to the studies.
Work with the eTMF Administrator to identify and help resolve system-related issues as needed.
Review the TMF scope of work for assigned studies, identify out-of-scope activities, and report them to department management for change order consideration.
Provide regular TMF status updates to Project Leadership and Functions on the quality and timeliness of document submissions.
Assist with monitoring the security, environment, and access control of Secure File Room facilities, if applicable.
Monitor compliance with TMF SOPs and TMF Plans for assigned studies.
Provide live, web-based, and/or recorded TMF process and systems training to Premier project teams, Sponsors, and other third parties.
Perform all departmental budgeted activities for assigned studies.
Develop, sign, and maintain TMF Plans, TMF Transition Plans, and indexes for assigned studies.
Participate in TMF audits and inspections as the TMF representative for assigned studies.
Coordinate project team quality reviews of TMFs in accordance with TMF SOPs and TMF Plans.