[Hiring] Trial Master File Lead @TFS HealthScience

Role Description

As part of our CDS Therapeutic area / Ophthalmology team, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals. The Trial Master File Lead is responsible for organizing, maintaining, and overseeing the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, PM delegation, and coordinating main tasks under TMF Business Line. This role may act as Line Manager for TMF Associates.

• Create the Study TMF EDL in cooperation with PM (Project Manager) and study team.
• Create the first draft of TMF Plan, implement changes after review, generate final version, and distribute final version to the study team.
• Create TMF at Trial, Country, and Site Level (paper TMF).
• Control if the Electronic Trial Master File (eTMF) at Trial, Country, and Site Level was properly created by Clinical Business Administrator (CBA) team when TFS system is used.
• Inform the study team that TMF is created and ready for document upload for eTMF or submission to paper TMF (pTMF).
• Actively follow up with the study team to ensure documentation is submitted following the process described in The TMF Plan and that the TMF is always audit and inspection ready.
• Set up the Investigator’s File as directed by Clinical Research Manager (CRM) and forward the CRM a tracker of all document sections within the ISF. This activity may be delegated to TMF A and/or Project Management Associate (PMA) depending upon study needs.
• Actively collaborate in the training of the study team regarding the TMF workflow and management.
• Act as contact person for the study team to support TMF doubts or TMF issues and ensure TMF is always inspection ready.
• Maintain and follow up TMF status, identify areas with missing documentation and inconsistencies, and follow up with the study team for resolution.
• Perform Quality Check of each document before filing in TMF and follow up issues until resolution.
• Perform Quality Check of each uploaded document after filing in eTMF and follow up issues until resolution.
• Responsible for creating and maintaining paper TMF (pTMF) tracker and generating reports for eTMF.
• Generate metrics supporting TMF completeness and accuracy.

Qualifications

• 5 and above years of proven relevant experience in Clinical Trials with TMF management including oversight and quality control.
• Deep knowledge of GCP/ICH guidelines.
• Strong understanding of the impact of the TMF on Study management.
• Strong written and communication skills and demonstrate ability to communicate and coordinate within the group of TMF stakeholders.
• At least 1 year of proven people management.

Benefits

• Competitive compensation package.
• Comprehensive benefits.
• Opportunity for personal and professional growth in a rewarding environment.
• Joining a team that values collaboration, innovation, and making a difference in the lives of patients.

Company Description

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.

• Core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making.
• High employee engagement and satisfaction through alignment on fundamental values.
• Fostering a culture of mutual respect and collaboration.