TMF Associate

Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study setup to transfer / archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to theTMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and accessmanagement framework. Work proactively and successfully within a cross-functional team. Communicate and promote department andcompany goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses aprofessional and helpful attitude. Time allocated may be adjusted based on need.

Service Delivery

• Serveas the primary TMF contact for assigned studies
• Ensure TMF is completeand “inspection ready” throughout study lifecycle and documents are filed contemporaneously
• Work with Team Leadto create study specific TMF management and oversight documents (e.g., File Index, Expected Document Lists and TMF Management Plan) in alignment with study
• Develop and maintainstudy-specific work instructions, as needed
• Utilizeorganization skills to maintain a quality control schedule and perform periodic inventories of study TMF to ensure completeness
• Review andcommunicate out-of-scope and / or incomplete documents to study teams; escalating as needed
• Reconcile expecteddocument lists based on study events and milestones
• Prioritizeand resolve TMF help desk tickets; may include triaging activities
• Provide study specificTMF training to internal and / or external stakeholders, as needed
• Process andreview documents, following applicable scanning and best practices and bestpractices, and applying ALCOA principles appropriately
• Fileand retrieve TMF documents in a timely manner

Department Support

Qualifications

The ability to incorporate the principles of ALCOA in relation to TMF oversight.

Utilize skills in time management and problem-solving. Identify challenges and problems and take the initiative to identify solutions.

Demonstrated computer literacy, proven functional knowledge of Microsoft packages and potential to develop

Working Conditions

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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