Trial Master File Study Owner/TMF Lead

ROLE SUMMARY
The clinical trial documentation must be consistent with the Trial Master File (TMF) specifications, submission/ inspection readiness criteria and comply with applicable Standard Operating Procedures and other requirements.
Trial Master File (TMF) Study Owner (SO) is an expert and single point of contact for the Project Manager (PM) or equivalent and study team to ensure a complete and accurate TMF through documentation quality and consistency across clinical trials and programs.

ROLE RESPONSIBILITIES

• development and assistance with the implementation of the TMF specifications, such as process and system changes.
• determination of course of actions to prevent and remediate timeline delays.
• consistent use of standardized processes and technologies across clinical trials and programs.
• identification of continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.
• support and guidance to the study teams to drive performance against metric targets.
• education, feedback and support to study teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.

• review of study specific TMF specifications to ensure quality and standardization are established per program and kept up to date as program/protocols progress.
• the preparation of appropriate audit and inspection responses.
• ownership and accountability across study teams regarding readiness of TMF documents.
• communication and interaction among study team members from the set up until the closing (e.g., TMF Lock) of the TMF for a clinical trial.