Clinical Research Project Manager Interview Tips and Strategies
The other day I received a question from someone which read like this: “I have moved to the US and have an interview with a CRO for a Project Manager position within the next 10 days. During the interview I will be asked to give a 15 minute presentation on the following topics: throughout your career you have experienced problem solving in a team environment, from your experience what are the top three things that disrupt effective problem-solving and provide one real life example of each.”
Welcome to the corporate world. They want to assess your reasoning, critical thinking and problem solving skills. Here are my top 3 things that disrupt problem solving in the clinical research industry:
1.) Lack of expertise
One typical Project Management issue is CRA’s that are not able to solve problems effectively, and ultimately, the problem will come back to you. You will need to retrain the CRAs on protocols and perhaps a little about the therapeutic indication. A way to go about solving this problem that would set you apart from all the other interviewees is mentioning that CROs are hiring clinical trial educators, who are also RN’s(registered nurses), whose primary job function is to work with the research sites and have a deep knowledge of the therapeutic indication for that particular study they are assigned to. You may want to bring a medical monitor into mix and have them reeducate all the CRAs or at least the ones having problems, specifically on the therapeutic indication. Talk about adverse events we are noticing in the trial. CRO’s are utilizing risk-based monitoring right now and you can pull this data in real time. You can then show your CRA the adverse events you are noticing and also show them the sites that are not reporting these adverse events. The medical monitors can also explain how the drug may or may not cause those adverse events and maybe the CRA can actually talk to their respective PI about this. The CRA may need to reeducate the PI and the site on the protocol.
2.) Lack of Resources
Most CRAs are overworked and rarely have time to do 100% source data verification even when considering risk based monitoring. Increasingly more CRO’s are moving away from this 100% source data verification and more of the responsibility is falling on the research sites. Risk-based monitoring is a way for CROs to avoid having to hire even more CRAs because doing so is expensive. Therefore, SDV responsibilities and quality assurance responsibilities are transferred to the site. CROs are for profit companies and rather than hire more CRAs they came up with risk-based monitoring because they can manage the trials more efficiently. It still remains to be seen if it really is more efficient. It’s way too early in the game for that. We are barely starting to see it implemented. Time will tell if it is a good or bad idea but your goal here is to get hired as a project manager. Lack of resources is definitely a big one but you may not be able to get the resources you need. I would integrate the resources that you have and make them work synergistically. We can do that by leveraging different individuals already present in your organization such as the clinical trial educators, the medical monitors, the CRAs, and perhaps clinical trial assistants.
3.) Lack of Communication among team members
If you have a particularly large protocol (ex. 100+ CRAs on a study), you could hold weekly meetings amongst the members and perhaps group them into regions. Groups of CRAs can discuss problems they are noticing at their sites and other CRAs can engage in dialogue with their colleagues that can bring everyone’s focus on certain key items/issues. Pay attention to the CRAs that have high-enrolling sites and make sure those sites have sufficient CRA coverage. A perfect example of this is Southern California. The region has a lot of research sites that typically enroll a high volume of study participants and usually there are only one or two CRAs assigned to all of these sites. The bottom line is that you do not want just one or two CRAs having responsibility for all of those sites. It is not fair and as a result, you end up getting a disproportionate amount of data to be reviewed, queries to resolve and other related issues passed on to a few CRA’s. They won’t even have time to keep up with all of their sites much less have any kind of communication amongst their own colleagues or with their team members. As a project manager, make sure you have allocated your resources effectively.
