July 22 2016 Stacy Surensky, CPC

Last year in our blog post titled “The New Clinical Data Manager,” we wrote about some key changes to the clinical data manager role that have taken place in recent years. What is fascinating to me is the pace at which the versatile position continues to evolve. Having worked on both the sponsor side and the CRO side in various Clinical Development roles, I have never seen this role change as rapidly as it is changing today.  To stay ahead of the curve there are five critical areas of growth that I believe all data managers need to be aware of:

  1. The acceleration of clinical trials due to new technology

Sponsors and CROs today are striving to accelerate the pace at which clinical trials are conducted, analyzed, and reported on in order to shorten the time to market for new treatments. And increasingly they are looking to technology for assistance in generating, collecting, cleaning, and analyzing data. EDC and use of Data Visualization tools are prime examples.

With EDC systems reducing the need for manual data cleaning, we CDMs find ourselves having to manage ever-larger volumes of increasingly complex information and needing to ensure that it is analyzable. Mobile health data will be adding to this flow, and we must be prepared for how to incorporate this sometimes less-than-perfect data into studies. Rather than solely focusing on the individual data points one at a time, we are being asked in our new role to look at the data as a whole. This is a major change, and it necessitates a greater level of collaboration with site monitors and biostatisticians than ever before, placing a new premium on our communication skills.

Continuous evolution and affordability of technology in clinical development puts a high demand on data managers to utilize the most recent technology advances for the benefit of clinical trials and subjects.  Patient-centric environment and a public demand for pharmacoeconomic data drive ever more frequent utilization of ePRO and wearable devices in a broad variety of indications. Today, CDMs are keen on integrating validated technology solutions for comprehensive data collection, leading the way to the future of Clinical Development.

  1. Cross-functional collaboration

There is a need to better collaborate across the many functions within a trial. This can be a tremendous challenge considering that, depending on the type of study and the way the CRO and sponsor are staffed, teams may be working for different types of organizations. Additionally, study teams can include anywhere from five to 10 or more different functional roles.

Both within a CRO and extending to the trial sponsor, the need to replace the silo mindset of the past with a more interactive, communicative approach has never been greater. Even very basic steps like conducting an online eCRF review session before the data collection and cleaning tools are finalized and having regular meetings as the study progresses help ensure that the aggregate knowledge of the group is leveraged most effectively. In particular, having the CDM, the CRAs, and the clinical project manager connect more frequently is imperative.

With the introduction of Risk-Based Monitoring and targeted SDV, a critical need to collaborate with the clinical teams in a new capacity spirals to new heights.  With the CRAs spending less time verifying source data, the Data Management teams take center stage leading the data quality assurance using smart tools and technology.  Collaboration with our clinical colleagues to co-create carefully calculated and executable Data Quality plans are a key step leading to data integrity and ability to accelerate data locks.

  1. Moving from a peripheral role to a pivotal one

In the past, the expectations of the CDM position limited the data management role to data review. Today we have taken on a more central position in clinical trials. While the majority of our time is still spent on the verification, clarification, and validation of data, with the advent of risk-based monitoring, we now play a pivotal role in focusing attention on problematic data sources (sites, countries, specific CRFs) early on in an effort to mitigate their impact on data integrity.

For example, the CDM can point out sites that are slow to provide data after a patient visit, that change data points frequently, fail to respond promptly to queries, or have many protocol deviations. In short, we are tasked with helping troubleshoot trials, but that requires having a much more comprehensive, “big picture” understanding of how the protocol was developed, how the data is being collected, a solid understanding of data quality standards, data trends, and the sponsor’s goals.

Also, more and more today our overall grasp of the data is resulting in other functional roles looking to us for our insights on other key advancements in Clinical Development, such as Real World Evidence (RWE), trial feasibility management, market access, pharmacovigilance, and genomics. As the experts in the unique position of being most familiar with the data while also understanding the trial’s parameters and goals, we are increasingly getting the opportunity to present the data and manifest our contribution to the study.

  1. Project management skills

As the role of the CDM continues to evolve, it is clear that we will benefit from having essential project management skills that were not as critical in the past. As each step of a trial is progressing, there is a trend to expect CDMs to be ready to provide immediate answers as to how accurate and complete the data is, and to lock the database as soon as the last subject has completed the study. This requires us to have an in-depth understanding of study endpoints, a good grasp of the project contingencies, advanced prioritization, and time management skills.

In fact, that expectation has begun to affect hiring decisions. Project management experience is now frequently included as a prerequisite on job postings for CDMs. Even when it is not specifically mentioned, savvy job seekers understand that a background in project management – everything from scope and timeline management to quality control – will increase their chances of landing an interview.

  1. Critical thinkers

People in other roles within the trial want to be reassured that we are looking critically and comprehensively at the data. They need us to help them interpret what the metrics mean, what trends are being revealed, and how the data trends can best be used for clinical decision making. That starts with fully understanding the study protocol.

This requires more than just reading it. We must intellectually dissect it, researching the clinical indications, leveraging our familiarity with similar protocols, consulting with our cross-functional colleagues, and calling on whatever other resources it takes for us to master the subject. Our teammates often look to us to understand the clinical meaning of the data points and coded terms, not in isolation, but in relation to one another. This depth of comprehension can’t be gained by simply searching the protocol for keywords and reviewing a schedule of assessments. There is a role for us to share our own insights and provide input to the best data collection practices based on our expertise.

A Bright Future for CDMs, CROs, and Study Sponsors

I find the expanded responsibilities of the new CDM role to be both challenging and exciting. With greater responsibility comes increased recognition and opportunities for career advancement. More importantly, there is a greater sense of contribution and accomplishment.

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