Written by Nicole M. Palmer and John R. Nocero
When you are considering a career in the clinical research industry or looking to make a career shift it’s crucial to research and dive deep on the various roles available within the Trial Master File (TMF) to find your perfect fit. The TMF is an essential component of clinical trials, containing all the necessary documentation to ensure that the records tell a story of what happened in the trial. Within the TMF, different roles play unique and vital parts, making it imperative to be granular with your search in your potential career path.
I was thinking about the principle of specificity Nikki and how it applies to us. Over the last year, we have really gotten specific on what we both want and the personas we put out into the world, as well as LinkedIn. You are the TMF girl living in the TMF world, and I am the Director of Quality, Just Like Becky. Both of us have gotten rewarded for it as well. You were recently named as one of the Top 5 TMF experts to follow on LinkedIn by the Business Anecdote (congrats again btw) and I now am running both quality departments for Flagship Biosciences while reaching the pinnacle of my life with my Shero on Monday Night Raw on May 15.
Now, here’s the thing – I don’t believe either one of us would have gotten here if we didn’t really get specific on what we wanted. It would not have happened. As you look to empower the next generation of professionals, have you seen people getting specific on what they want and then following through? Think about it for a second – you ask people what they want, and they really don’t know. Why? How do you not know? Someone said to me the other day, “God, John, you are really so sure.” Of course, I am. I know who I want, what I want, why I want it, and what it would mean to me to get it. I also know the work I have to put into it to get it and I am willing to do that work also as you are.
I wonder sometimes, do people just not know what they want or do they know and they are not willing to put in the work to get it? Maybe a combination of the two?
I don’t know about you John, but it took me a long time to figure out all the different roles in clinical research and their respective responsibilities. I started my career in clinical research as a part-time Clinical Trial Administrator (CTA), and part-time Administrative Assistant and I also, worked part-time at a Help Desk for sites that needed assistance with IVR, IWR, and IMR. Later I transitioned into a full-time CTA and after a few years, I wanted to explore different roles.
My first leap was wanting to be a Project Manager. I was working hard to make the transition and really learn the role. After thoroughly learning all about Project Management, I learned that that was not the right role for me. They have a lot of responsibility and carry a lot of weight on their shoulders. During that time, I learned that they have strict timelines, provide study updates (the good and the bad!), risk mitigation, ensure that we are on task with the budget, and monitor the progress of the study. I’ve seen sponsors say that they don’t want to work with a particular Project Manager (PM) and wish to have a different PM assigned to their study. To think, if I were ever in that situation, how would I handle it?
I changed my career goal and wanted to be a CRA. I was single with no kids and it made perfect sense. How cool would it be to travel, stay in a nice hotel, go out to eat, and explore other places? Fact check: it’s not as glamorous as it sounds. It was actually exhausting, and you didn’t really have much time to explore. I can remember the first time I was on site. I thought I’d be in a fancy office to review the reg binder. Ha! It looked more like a claustrophobic closet. I also remember my first SIV in Maine. I was so excited because I had never been to Maine before and all I wanted was to try a Maine lobster for the first time. Then, I found out I was 8 weeks pregnant, and I did everything by the books. My doctor told me, no shellfish. Here I was headed to Maine and couldn’t eat a Maine lobster. After careful consideration, I decided that being a CRA wasn’t going to work out for me with a newborn.
The funny thing here, I was constantly trying to figure out other roles in clinical research, but something kept bringing me back to the TMF. I decided in order to have the best work/life/balance (if there’s such a thing) I’d be a TMF Manager. This role ended up being my favorite and I got to use a lot of my transferable skills as a landlord. What do I mean by this? With my rental properties, I had to advertise my rental, show the property, have the potential tenants fill out an application and I would call and verify everything they put on their application and also required a background check. These types of transferable skills I could use to my advantage in the screening and hiring process for potential TMF candidates. With that said, let’s explore 5 TMF roles and their contributors.
1. TMF Lead/Manager: This role involves overseeing the entire TMF process, ensuring the timely completion and accuracy of all essential documents. TMF managers collaborate with various stakeholders, such as clinical teams, sponsors, and regulatory to ensure compliance with the regulatory requirements and guidelines. They provide guidance to other team members, manage the TMF system and maintain it’s integrity.
2. TMF Specialist/Coordinator: TMF specialists or coordinators are responsible for managing and maintaining the TMF throughout the clinical trial. They perform document quality checks, track and organize documents, and ensure proper documentation according to regulatory requirements and guidelines. They work closely with study teams, investigators, and other stakeholders to collect, review and archive essential trial master file documents.
3. Document Control Specialist: Document Control Specialists focus on ensuring the integrity, accuracy, and accessibility of trial-related documents. They develop and implement document control processes, maintain document repositories, establish version control, and enforce document retention policies. Their attention to detail must be top-notch in maintaining an audit ready TMF and facilitating efficient document retrieval during inspections or audits.
4. Quality Assurance Specialist/Auditor: Quality Assurance or Auditors play a critical role in ensuring the TMF’s compliance and quality. They conduct regular internal audits, identify compliance gaps, and provide recommendations for corrective and preventative actions. These professionals are knowledgeable about regulatory requirements and guidelines and collaborate closely with TMF Managers and other stakeholders to ensure adherence to best practices.
5. Regulatory Compliance Specialist: Regulatory Compliance Specialist focus on ensuring that the TMF and associated trial processes align with regulatory guidelines and requirements. They keep up to date with regulatory changes, review trial documentation for compliance, and provide guidance on regulatory requirements. Their expertise ensures that the TMF meets regulatory expectations, reducing the risk of non-compliance and delays in the trial processes.
Understanding these distinct roles and responsibilities is crucial when researching a career within the TMF domain. It’s just as important to know what you like and more importantly to know what you don’t like when it comes to responsibility. By exploring the intricacies of each role, you can identify your strengths, align them with the specific responsibilities, and determine the path that suits your interests and aspirations! Researching these roles at the granular level allows you to gauge the skills, qualifications, and experience necessary for success in each position.
Nicole & John
P.S. Remember, a well-informed career choice sets the foundation for professional growth and fulfillment. If you learn about the different TMF roles and align them with your passion and skills, you increase your chances of finding a rewarding career within the clinical research industry.