Trial Master File Associate

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 (1.0 FTE) - home based in POLAND.

About this role

As part of our CDS Dermatology team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Trial Master File Associate is responsible for organizing, maintaining and overseeing 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 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.

Qualifications: 

• 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.

What We Offer

We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. 

Together we make a difference.