PharmaLex is hiring a
TMF Study Owner

Summary

Join our team as a TMF Study Owner to ensure clinical trial documentation is consistent with Trial Master File specifications and complies with applicable SOPs. Key responsibilities include contributing to the development of TMF specifications, leading the setup of the TMF Study Specific Document List (SSDL), and serving as a point of contact for internal and external audits.

Responsibilities

• Contribute to the development and assist with the implementation of the TMF specifications
• 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
• 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