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TFS Health Science 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 (TMF Associate) - office based in Barcelona, Spain).
About this role
As part of our Trial Master File team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Trial Master File Associate (TMF Associate) is 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 e TMF or submission to p TMF
- 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 Ao R completion and monitoring TMF transfer/shipment to the Sponsor
- Ensure delivery of fully executed TMF Ao R to TMF Functional lead
Qualifications:
- At least 1 year of experience in CRO or Pharmaceutical Industry with proven Trial Master File (TMF) experience
- 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
- Teamwork ability
- Effective time management
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 27 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 800 professionals, TFS delivers tailored clinical research services in more than 40 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.