Trial Master File Associate

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Organizing, maintaining and overseeing the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, TMF Functional Lead and PM delegation • 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

🎯 Requirements

• At least 1-5 year of experience in CRO or Pharmaceutical Industry with proven TMF Management • Bachelor’s Degree in Health Science or Document Management or equivalent work experience is preferred • Knowledge of GCP/ICH guidelines • Good written and communication skills • Good organizational and multi-tasking skills • Good software and computer skills • Able to work in a fast-paced environment with changing priorities

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaboration and innovation in a rewarding environment