What is tmf specialist?
In working with those interested in starting a TMF career, one of the most common questions we get asked is: “How do I get a job in working with the TMF without much (or maybe any) industry experience?” While it is challenging to break into any new career, the right knowledge can help efficiently direct your effort and land you the TMF job you’ve been dreaming of. In this post, we’ll introduce the role of TMF professional, shine a spotlight on industry demand for TMF talent, and examine what jobs are available to the newest TMF professionals. In upcoming posts, we’ll consider the education, experience, and skills necessary to become a TMF professional.
What Does a TMF Professional Do?
The TMF, or Trial Master File, is the collection of documents that record the story of a clinical trial. Regulators use these documents to ensure a clinical trial subjects’ rights were respected and that the data produced by the trial is valid. A TMF professional performs one or many aspects of the set-up, maintenance, close-out, inspection, or management of this collection of documents. The foundation of any TMF role is the individual regulatory documents that comprise the TMF. A new TMF professional might focus solely on collecting these regulatory documents from clinical trial stakeholders, ensuring the quality of the individual documents is acceptable and filing these documents in the right location. More experienced TMF professionals might have the opportunity to audit TMFs all over the world, to manage those who maintain the TMF, or to determine the overall structure of a TMF critical to supporting a billion-dollar drug submission.
What is the Demand for TMF Professionals?
Clinical trials and the TMF have changed rapidly in the last few decades and the pace of change is ever increasing. A large part of this change comes from the industry’s shift towards embracing new technology, especially technology that replaces paper TMF documents with electronic TMF documents. This transition from paper TMF to electronic TMF (or eTMF) was made necessary by regulators’ expectations that the TMF provide ever greater detail and visibility into the conduct of a clinical trial. This increase in clinical trial complexity and TMF regulatory expectations means employers need more skilled clinical trial professionals than ever, including TMF professionals. According to a 2020 survey conducted by the Association of Clinical Research Professionals (a respected clinical trials industry group), monthly job postings for all clinical research positions have increased 9.3 percent over the past three years. Factors related to COVID have further increased the pent-up demand for clinical research services and skilled professionals to even greater levels than during the 2020 survey. For those who can position themselves to meet the minimum requirements for entry, now is one of the best times to become a TMF professional.
What Entry-Level TMF Jobs Are Available?
Overview. The TMF Specialist is responsible for supporting a high quality TMF, performing quality checks, archival and retrieval of records for the Trial Master Files (TMF).
