TFS HealthScience is a leading integral 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 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 transfer/shipment to
the Sponsor. Ensure delive

📌 Trial Master File Associate (Comunidad Valenciana)
🏢 TFS HealthScience
📍 Comunidad Valenciana