Associate II, TMF Operations - EMEA- Fixed term - Remote
About this role
Associate II, TMF Operations - EMEA- Fixed term - Remote
What you will do Fulfil the TMF Approver and/or TMF QC Reviewer roles as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices. Process, review, and resolve rejected Trial Master File (TMF) documents, for complex studies or Sponsor portfolio of studies both in an electronic and hard copy format. Prepare periodic TMF Quality Control checklists for review by Project Team review. Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices. Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents
What you will bring to the role Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions
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