Trial Master File Lead

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 Lead [1.0 FTE] - Home based

About this role

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

The Trial Master File Lead is responsible for organizing, maintaining and overseing the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, PM delegation and coordinating main task under TMF Business Line and may act as Line Manager for TMF Associates.

Key Responsibilities: 

• Create the Study TMF EDL in cooperation with PM (Project Manager) and study team.

• Create 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 to study team that TMF is created and ready for document upload for eTMF or submission.

  to paper TMF (pTMF)

• Actively follow up study team is submitting documentation following the process described in The

  TMF Plan and that TMF 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 collaborates in the training to study Team regarding the TMF workflow and management.

• Act as contact person for study team to support on TMF doubts or TMF issues and support study

  team to 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 finding’s 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 to create and maintain paper TMF (pTMF) tracker and generating reports for eTMF.

• Generates 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 the 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.

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.