TMF Associate

Overview

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 the TMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and access management framework. Work proactively and successfully within a cross-functional team. Communicate and promote department and company goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a professional and helpful attitude. Time allocated may be adjusted based on need.

Service Delivery

• Serve as the primary TMF contact for assigned studies.
• Ensure TMF is complete and “inspection ready” throughout study lifecycle and documents are filed contemporaneously.
• Work with Team Lead to 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 maintain study-specific work instructions, as needed.
• Utilize organization skills to maintain a quality control schedule and perform periodic inventories of study TMF to ensure completeness.
• Review and communicate out-of-scope and / or incomplete documents to study teams; escalating as needed.
• Reconcile expected document lists based on study events and milestones.
• Prioritize and resolve TMF help desk tickets; may include triaging activities.
• Provide study specific TMF training to internal and / or external stakeholders, as needed.
• Process and review documents, following applicable scanning and best practices and applying ALCOA principles appropriately.
• File and retrieve TMF documents in a timely manner.

Department Support

Qualifications

Working Conditions

$52,500 - $87,500 a year

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