Trial Master File Associate

1 giorno fa

Rome, Italia TFS HealthScience A tempo pieno

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. Join Our Team as a Trial Master File Associate - home based in Poland, Italy or Israel or hybrid in Barcelona, Spain About this role As part of our CDS Ophthalmology Trial Master File team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Trial Master File Associateis 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 pTMFDevelop TMF PlanProvide 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 metricsEnsure TMF processes timely implementation and executionAdjusting 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

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