Senior TMF Lead

Position Summary:

• To act as the Functional Lead for Trial Master File (TMF) Services with responsibility for delivery of all aspects of TMF. 
• Responsible for setup, maintenance and close of TMF. 
• Responsible for the complete and accurate Trial Master Files through documentation of quality, consistency and timely filing across all assigned clinical trials, consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines, regulatory agency and any other local authority requirements

Job Responsibilities:

• Lead the setup of the Study in TMF system.
• Drive completeness and quality of TMF content for all assigned clinical trials until study close out. Manage TMF activities in accordance with the contracted budget for TMF Operations.
• Lead the development and implementation of the TMF specifications, such as process and system changes.
• Primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses.
• Effectively monitor and report on progress of the TMF to all stakeholders.
• Facilitate communication and interaction among study team members from the set up until the closing of the TMF for a clinical trial.
• Provide education, feedback and guide Study Teams, TMF leads and TMF specialist in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
• Determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.
• Assess impact of potential changes to TMF specifications prior to implementation; collaborate with Sponsor Support Team, PM or equivalent if modifications are necessary.
• Maintain Study Specific Document Lists (SSDLs) at the study, country and site levels by collaborating with all relevant Functional Lines (e.g. Data Management, Clinical, Regulatory, etc.) to ensure placeholders are correctly and accurately in place for the study and all versions and instances are filed in a timely fashion.
• Conduct periodic quality review of Study Specific Document Lists (SSDLs) at all levels and liaise with the Functional Line Document Owners to ensure that all findings are addressed and remediated in a timely manner.
• Provide support and guidance to the TMF Owner Group to drive performance against metric targets and resolve guidance conflicts and issues.
• Support TMF Owners and Study Teams in addressing/reporting regulatory queries pertaining to TMF Operations.

Experience required:

A minimum of 9 years of clinical research industry experience in operations/Clinical records management Regulatory/Quality or equivalent position/experience.

Any life science graduate