LMK Blog

Skeletons in the Closet Don’t Be the Next TMF Horror Story

October 18, 2021

It’s the time of year for scary stories. Usually these involve haunted houses, zombies, ghosts, and/or reanimated skeletons and are a welcome catharsis balancing the sugar high of pumpkin spice lattes and snickers bars. The most chilling stories, though, aren’t confined to the month of October. We are, of course, talking about TMF horror stories.…

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

August 23, 2021

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 working with the TMF without much (or any) industry experience?” At LMK it’s not just our mission to be the best TMF professionals we can be, it’s our mission…

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

August 16, 2021

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…

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A TMF That Works With You: Achieving TMF Process Sustainability

August 9, 2021

Sustainable TMF processes are stable, repeatable, and scalable. Unsustainable TMF processes are poorly defined, constantly changing, time consuming, and introduce compliance risk. They make the workday a challenge and are a constant obstacle to our TMF goals. Nobody actively seeks to make a process unsustainable, of course, but achieving TMF process sustainability isn’t easy. Without…

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Facing TMF Bias: My Role is Not Entry Level PART THREE

May 14, 2021

Part Three: We begin with the end in mind. I’ve heard your TMF department has a revolving door. Contractors and young, fresh faces constantly churn through their first day on the job and last day in the office. This need not be the reality. There is no revolving door where I work. My team has…

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Facing TMF Bias: My Role is Not Entry Level PART TWO

April 27, 2021

Part Two: I tenaciously strive for TMF success. I’ve heard your TMF department has a revolving door. Contractors and young, fresh faces constantly churn through their first day on the job and last day in the office. This need not be the reality. There is no revolving door where I work. My team has left…

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Facing TMF Bias: My Role is Not Entry Level PART ONE

April 20, 2021

I’ve heard your TMF department has a revolving door. Contractors and young, fresh faces constantly churn through their first day on the job and last day in the office. By the time they are proficient, they leave to embrace a new specialty. This need not be the reality. There is no revolving door where I…

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The Importance of a Single Document

February 4, 2021

While working within a Trial Master File (TMF), it can often seem like there is no end to the number of documents needed for a clinical research study. There are multiple documents for different aspects of a study – from trial management to site management, safety, statistics, data management and everything in between. But one…

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Where Should I Begin?

February 4, 2021

Experience in various roles within clinical research greatly helps with having an understanding of the Trial Master File (TMF) but it’s not always necessary to have decades of experience in clinical research to be an effective TMF Analyst or Auditor. The most important thing to keep in mind when performing a TMF Quality Control (QC)…

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