During our recent webinar, Add Data Management to Your Clinical Research Resume and Expand Your Professional Potential, Shannon Labout of CDISC and Shannon Roznoski of Forte discussed why quality data management practices are critical to clinical trial success. The two expert presenters also provided many resources for research professionals to continue their clinical data management education and grow their careers. Here we transcribed five of the valuable responses Shannon L and Shannon R provided during the question and answer portion of the presentation.
You can also watch the full, on-demand recording of the webinar and download the presentation slides, including all links to resources mentioned during the webinar, here.
How can I convince leadership to support professional development in data management?
Shannon Labout: One of the things we provide on the Society of Clinical Data Management (SCDM) website is an example letter that you can use to talk to your manager about the value of sending you to a conference, for example. There are a lot of good ideas in there about how it benefits the organization and not just about how it benefits you. You’re actually using that good information you gain at the event to help your organization make things better.
Shannon Roznoski: I agree it’s a great idea to stress the benefit to the organization as a whole. Any opportunity for an individual to take a class, attend a webinar, get a certification, etc. expands that person’s knowledge of the research industry and allows them to bring that back to their organization to improve processes and standards. I think it’s a strong argument that you can make.
Do you have tips for how to prepare for the certification exams?
Shannon Roznoski: Most certification exams, and definitely the SCDM and Society of Clinical Research Associates (SOCRA) exams, do offer a study guide. If you’ve already been working in the field for a couple of years and you’re doing data management activities, I’ve found it’s possible to download the study guide and study from that, then schedule the certification exam. Most organizations that offer certifications will also offer webinars, workshops or classes. If you do have a training budget, that could be an option to help you prepare.
Shannon Labout: A lot of organizations, especially if they want several people in their organization to become certified, will form study groups and have different people conduct deep dives into the Good Clinical Data Management Practices (GCDMP) chapters. This is a great way to learn something very thoroughly—to teach it to someone else.
Do any of the certifications mentioned during the presentation, such as the GCDMP and CCRP, need any prior certification to be completed?
Shannon Roznoski: No, the certifications don’t require other certifications, but I did mention there are some experience and/or education requirements. It’s best to read the requirements for any certification that you’re looking at pursuing. If you have a degree in a related field, the amount of experience working in that field is often lower, and vice versa. Requirements tend to be around two years of experience working in the field.
How do I break into the data management field with no prior experience?
Shannon Labout: If you ask 10 different data managers how they got into data management, you’ll probably get 10 different answers. Until recently, most people weren’t able to get a degree in data management. There are now some degrees available. However, if you’re already in another field, it really depends on your background. You may have to start from the bottom and just learn everything from the ground up by taking a more entry-level position.
Shannon Roznoski: Yes, historically there have not been degree programs for data management and even a lot of clinical research, but like Shannon L said, that is starting to change. On the other hand, if you’re mid-career and trying to switch to a new career, going back and getting another degree might be a challenge. So, it can be helpful to transfer into a data management research organization, or if you work at a university, get involved in the clinical research and data coordination activities there.
Honestly, getting a certification before you have the job—getting the certification for the job you want—is the approach I took. My background prior to my data management-related roles was in the IT realm. I was acting as application developer and business analyst in IT at a research organization, and I started working towards certification pretty early on after I decided to transition into a more clinical research-focused role. Also, if you work for a larger organization, mentorship programs may be available. This could allow you to meet with and develop relationships with people in other departments or groups that are doing the work you’re interested in doing.
Shannon Labout: Mentor programs are a great idea. I love cross-functional collaboration; anytime we can do that, it’s a great thing. One of the things that I offered in one of my data management groups—because I had a good working relationship with the manager of clinical operations—was a little bit of cross-training with members of each group. This allowed data managers to go out and perform site activities and introduced the CRAs and others to data management activities. It was a good way to give exposure to those roles and give people the opportunity to explore whether or not that would be a good career path for them.
What kind of data quality improvement efforts do you recommend?
Shannon Labout: This question is a difficult one to answer without the opportunity to assess the question-asker’s current processes, but I think a good place to start when trying to improve clinical data management practices is to look into the Good Clinical Data Management Practices document (GCDMP). In that document, there’s a set of best practices for each topic, such as creating data collection instruments, setting up EDC systems, doing SAE reconciliations, etc. I think comparing your processes to those best practices is a good way to start improving. Then looking more deeply into the document and other resources available to get more details about what good processes look like.
The white papers on the SCDM website are also a valuable resource. There are some topics that are so new they haven’t been added to the GCDMP. The most recent one is on mobile health technology in clinical trials and the paper covers what data managers should consider when they are starting to use mobile health technology in their studies.
Want more answers?
To learn more, watch the full, on-demand recording of the webinar and download the presentation slides, including all links to resources mentioned during the webinar.