TMF Study Owner

Purpose

As TMF Study Owner you will ensure that the clinical trial documentation must be consistent with the Trial Master File (TMF) specifications, submission/inspection readiness criteria and comply with applicable SOPs and other requirements. The TMF Study Owner (SO) is the subject matter expert to 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. The TMF SO is accountable to the PM or equivalent for all global trial master file responsibilities conducted internally as well as externally at the Alliance Partners (APs) and Contract Research Organizations (CROs). TMF SOs provide crucial TMF quality support to the Study Team and are expected to establish a proactive quality- focused partner-relationship with the Study Team.

Key Activities

• Contribute to the development and assist with the implementation of the TMF specifications, such as process and system changes.
• Lead the set-up of the TMF Study Specific Document List (SSDL) and monitor completeness and quality of TMF content for all assigned clinical trials until study close out.
• Ensure documentation flow is within projected timelines and determine course of actions to prevent and remediate delays/slippages.
• Ensure consistent use of standardized processes and technologies across clinical trials and programs.
• Serve as point of contact for internal and external audits of study TMF-related queries.
• Actively identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.
• Provide support and guidance to the Study Teams to drive performance against metric targets.
• Apply lessons learned to continuous improvement of documentation management practices across study teams.
• Provide education, feedback and support to Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
• Ensure that the program documentation supports the regulatory package requirements.
• 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 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.
• Support the preparation of appropriate audit and inspection responses.
• Support Study Team in the effective management of TMF when working external vendors.
• Analyze error trends in documentation and provide feedback to their management and the TMF
• Support Study Team to ensure document quality requirements are agreed to and met, according to Completeness, Timeliness and Quality metrics.
• Enforce ownership and accountability across study teams regarding readiness of TMF documents.
• Support study team in addressing/reporting regulatory queries pertaining to document management.
• Ensure complete TMF is in place at time of study close/submission.
• Support study team in resolving TMF content issues.
• Facilitate communication and interaction among study team members from the set up until the closing of the TMF for a clinical trial.

Required Skills & Experience

• Experience in management of medical/clinical study records and documentation.
• Experience/knowledge of ICH/GCP documentation requirements.
• Clinical Documentation Management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.
• Experience with the following application types: Electronic documentation management systems, web based data management systems, as required, and database utilization
• Outstanding verbal and written communications skills, combined with outstanding listening skills are required.
• History of achievement in a customer service role with demonstration of meeting customer needs and concerns.
• History of achievement in building strong customer relationships. Strong skills in negotiation and conflict resolution essential. Ability to remain calm and focused in high-stress situations is very important.
• Strong background in provision of high levels of Customer Service evidenced by positive feedback from customers