Facing TMF Bias: My Role is Not Entry Level PART TWO
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 their TMF bias behind. Where I work, a TMF analyst is not considered a filing clerk or administrative assistant. It is not a “step down” to leave a CRA or project specialist role to pursue management of the TMF.
Most importantly, my team knows my job is not entry level. As an experienced TMF professional, I draw on knowledge gained from hundreds of TMFs to bring a new level of expertise and quality to each clinical trial I am assigned. In this blog series, I’ve examined what key attributes a seasoned TMF professional uses to have the greatest impact on their team and organization. In this post, I’ll discuss a trait common to the most effective TMF professionals: a tenacious drive to achieve TMF success.
We embody grit.
Following up with stakeholder about missing documents is the most visible part of my role. Early in my career I was timid when reaching out about TMF quality issues. As I gained experience I grew in my confidence that the quality issues I identified were worthy of my colleagues’ attention. I also became a better advocate for my own role, recognizing that serving the needs of others must be balanced with the objectives of the TMF. When time is scarce and quality is in jeopardy, I’ll take the time to listen and understand your needs. I’ll take whatever action is necessary to move the trial forward—but I’ll also ask you to do the same for the trial’s TMF. I persevere because I am passionate about what we can achieve as a team.
We are the voice of the TMF.
The regulators who decide the fate of a clinical trial know little of our work culture, our effort, or the challenges we overcame to achieve TMF success. The TMF is the regulator’s only window into the conduct of a clinical trial and the quality of the data produced. As an experienced TMF professional, I am the voice of the TMF. Because of the years I’ve spent at my organization, I have built strong working relationships that strengthen the lines of communication across the project. I know how to best leverage the team’s expertise and have identified the right channels and most efficient escalation pathways to keep the TMF on track. I also know how to most effectively share the prospective trial management insights the eTMF provides. I speak for the TMF because, ultimately, the TMF will have to speak for us all.
Our confidence is contagious.
An experienced TMF professional knows how to influence others without leaning on authority. Possessing this skill is essential because a TMF professional works across multiple management structures, disciplines, and time zones. It is my role to observe and understand this diversity and adopt the right tools and style of communication in response. More often than not, common TMF problems, like a lack of TMF contemporaneousness, duplicate documents, or misfiled documents, can be resolved with a small investment of my time to educate the right stakeholders. I know that making sure you have the knowledge to meet your TMF expectations provides you the assurance that TMF success is achievable. Growing your TMF confidence can be the first step in an upward spiral of increasing TMF competence across your team and the entire clinical trial.
The pervasive and harmful industry bias—that every TMF role is entry level—undermines us all.
I think it’s time we all take a step together to grow in our TMF confidence. That can mean celebrating those who persevere through tough TMF challenges. It can mean normalizing honest conversation about the sometimes stressful reality of TMF quality. Most importantly, it means building everyone up by cultivating a kinder, friendlier, and more open TMF culture that rewards those who courageously champion TMF health. I promise, if you are willing to take the first step toward TMF tenacity, I’ll be right by your side.
Please check back for our next post in this series discussing how an experienced TMF professional always begins with the end in mind.