Trial Master File Associate

TFS HealthScience•Auburn, ME

5d•Remote

About The Position

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 Ophthalmology 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.

Requirements

At least 1-5 year of experience in CRO or Pharmaceutical Industry with proven TMF Management.
Knowledge of GCP/ICH guidelines.
Good written and communication skills.
Good organizational and multi-tasking skills.
Good software and computer skills

Nice To Haves

Bachelor’s Degree in Health Science or Document Management or equivalent work experience is preferred.

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 delivery of fully executed TMF AoR to TMF Functional lead.
Actively follow up that the study team is submitting documentation, EDL maintenance for eTMF in cooperation with study team, following the process described in The TMF Plan and that the TMF is always submission and inspection ready.