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 Italy, Israel or Spain
About this role
As part of our CDS Ophthalmology Trial Master File team you will work alongside passionate and innovative professionals to ensure our customers achieve their goals. The Trial Master File Associate 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