TMF Associate

Job Title: TMF Associate Employment Type: Full time, Permanent Job Reports To: Manager, TMF Operations Department/Unit Name: TMF Operations Job Summary: Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set up 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.

Positions Available: 2; Note this position is cross-listed in multiple countries.

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.

, File Index, Expected Document Lists and TMF Management Plan) in alignment with study.

• Develop and maintain study-specific work instructions, as needed.

Utilize organization.

Habilidades

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 best practices, and applyi.