My experience in the field of clinical data management dates to a time when we did everything on paper. Moving to an electronic data capture (EDC) system was a seismic shift for the profession. And, within the last five years or so, we’re seeing another significant shift: The role of the clinical data manager is changing.
More than ever before, we’re being called on to do programming, more robust visualizations, and work with statisticians to analyze the data. Having navigated years of changes in this field, here are five tips from my experience to help today’s clinical managers succeed in this new environment.
- Embrace data science. It’s happening quickly. Clinical Operations (ClinOps), IT, and data management were independent functions. The team would develop a protocol and hand it to the next team. However, as the siloed culture starts to become more integrated, clinical data managers will need to expand their skill sets to succeed.
- Take ownership. This is a moment where data management is being called into every aspect of the project’s lifecycle. Our team must own the data, make sense of it, and disseminate our findings to the whole team. Where our team used to operate “behind the curtain,” our role is becoming more visible and central to the entire project. For example, clinical data managers should bring all stakeholders to the table – ClinOps, statisticians, programmers, technology partners, and vendors – and walk them through the entire build phase to get everyone on the same page.
- Build flexibility into your plans. Given the complexity of today’s clinical trials, clinical data managers must think ahead and build flexibility into their plans from the beginning. My organization has multiple studies that use several databases. We need flexibility to pull together different datasets as we review data, which makes it easier for biostatisticians and programmers to see a full portfolio picture.
- Communicate early and often. Make sure every cross-functional group, as well as your vendor, is aligned with expectations at the beginning of the build process. We recently had a project where we could build a complex phase 2 trial in four weeks. A key factor in this successful outcome was the transparency that every stakeholder had with our goal, timeline, and changes as they occurred along the way.
- Explore AI and emerging technology. We are using AI now to present cleaner and more robust data visualizations. It helps our senior management make faster, more informed decisions. Exploring and building a platform that integrates AI in some fashion is essential.
This is an exciting time to be in clinical data management. As our role evolves and grows, we continuously have opportunities to shape how our teams help deliver treatments to patients more quickly.
LeRoy Stafford
LeRoy Stafford is Director of Data Management at Fractyl Health, a metabolic therapeutics company pioneering pattern-breaking treatments for obesity and Type 2 Diabetes, that uses Zelta™ clinical data management and acquisition platform.
