Trial Master File Associate

Job description

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 (1 FTE) - (home based in EU). About this role: As part of our CDS Ophthalmolog y team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Trial Master File Associate (TMF 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...