How to Get a Job Working with the TMF: Part One

If you’ve been following our blog posts over the years, it’s probably because you work with the TMF or would like to. But, despite all the TMF topics we’ve covered, there’s one we haven’t given nearly enough attention. That topic is you—your TMF career, your personal development, and your journey from TMF beginner to TMF mastery. At LMK it’s not just our mission to be the best TMF professionals we can be, it’s our mission to give you the tools to become your own successful TMF professional, whether you’re just starting out with the TMF or our managing several TMFs across the globe.

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?

As with most careers, the variety of opportunities available to a TMF professional grows with experience. The most common entry-level positions either support the general administrative aspects of a clinical trial, including the TMF, like clinical trial assistant, clinical trial coordinator, or clinical research coordinator, or are dedicated to the TMF, such as TMF specialist (although the TMF specialist role may or may not be entry level). Some other TMF-focused roles like TMF document specialist, document assistant, or document coordinator may have responsibilities that overlap significantly with the TMF specialist role but are more likely to be considered entry-level.

If you search these positions on an online job board, you’ll likely notice an unwelcome phenomenon: many of these entry-level positions ask for prior related experience. While frustrating, there’s no need to be discouraged. As we continue this series, we’ll discuss the formal education and experience requirements for these roles and reveal how aspiring TMF professionals can grow and demonstrate their skills in innovative ways to sidestep many of these formal requirements.