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hace 11 horas
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. About this role As part of our CDSOphthalmology Trial Master File team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.The Trial Master File Associate is is part of the TMF Delivery Business Line within Clinical Development Services (CDS) and will function operationally as a member of the Study Team with the responsibility to organize, maintain and oversee the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, TMF Functional Lead and PM delegation. Key Responsibilities Notify study team that TMF is created and ready for document upload for eTMF or submission to pTMF Develop TMF Plan Provide training on study specific TMF requirements, guidelines including TMF Plan Perform QC2 on documents and documents reconciliation Provide TMF Monthly Reports to PM, Line manager and Head of TMF Delivery Regularly check TMF metrics, follow up on detected issues, ensure acceptable level of metrics Ensure TMF processes timely implementation and execution Adjusting study specific TMF Index/EDL in the relevant files/ system as directed by the PM (Project Manager) Ensure valid forms and templates are implemented and maintained in the assigned projects Check status of duplicates, documents in error, size and path length (if applicable), follow up on necessary corrections accordingly Coordinate Monthly and Quarterly TMF Reconciliation by creating Action Plan and submitting relevant report on the status Ensure TMF AoR completion and monitoring TMF
