Let’s talk project management!  Project management in the clinical research space is a topic near and dear to my heart. I’m Dr. Jeff Kingsley, and welcome to another edition of Riding in Cars with Researchers. I have with me Dr. Christine Senn, who is a project manager extraordinaire!

Thank you, I appreciate it. You know, I’m having a pretty exciting week because we are expanding our Project Management Office, which we’ve definitely needed. Lots of project management during the time of all the COVID trials we’ve been doing, but so many others too.

Now, most research sites do not have Project Managers.  Most research sites, the Coordinator does everything soup to nuts. The Coordinator is the Project Manager without any project management training whatsoever. Why? Hopefully you agree with me that we need project managers in research. I don’t think I’m going out on a limb. Why do we need project managers in clinical research?

I would say just because clinical research is so complex. Protocols have gotten more complex, and we’ve all seen the studies showing that. All of it: how many trial awards we get, determining feasibility, doing patient recruitment for them, following the protocol, making sure all of your clinical operations and logistics are set up beforehand. Do you have all the kits you need (as that’s been an issue recently)? Are you doing all of the marketing? Have you negotiated the best budget? Have you used all of the ad money so that you can maximize patient recruitment? Are you meeting your enrollment goals? Are you meeting your timelines? All of it.

Paying attention to your enrollment rate, the anticipated enrollment closed date, whether or not you’re going to hit it. It really is complicated.

It is. Yeah. It requires quite a few spreadsheets. I mean very few of us I think that sites use project management software. Spreadsheets work great for it, but there’s a lot you have to track.  You’re tracking your quality, your timelines, your enrollment numbers, your enrollment rate. 

Project management is actually a thing. There are classes on project management. There are certifications. There are people that get a certificate saying that they have the stamp of approval. Is it worth it? Is that necessary?

I think it’s tremendous to go through the classes at the very least to learn some of the concepts and to really understand them and the flow of the various stages of a project. You have to put so much into planning or the execution’s going to fail. If you execute, but then don’t monitor it afterward, you might think you did a great job at a project, but it actually kind of falls apart once you get out of it as the project manager. So that’s part of it. Certifications like PMP, I don’t think it would be helpful as much in a smaller company in clinical research, but if it was a huge one, like a Sponsor organization or a CRO, it might be. I tend towards Agile or Scrum, personally.  

Let’s come back to that in a second. The knowledge is something that you do believe is necessary.

Yes.  

So, basically doing the classes, reading the books is necessary, but getting the certification probably only matters if you’re going to be employed by a bigger global organization, a CRO, or a Sponsor.

I would think so. I’ve studied for several certifications – including one I haven’t named yet, Lean Six Sigma – and they’re all wonderful. And I haven’t gotten most of them because I like things that are applicable. I’m just a very practical person. I think a lot of project managers are. I want what’s going to be useful for the company I work in. I wasn’t really doing it for any other reason than to be useful. It can help you get a job though, to have those certifications.  

And so you just mentioned a bunch of these others: Agile, Lean Six Sigma. How are they different from just being a project manager?

Absolutely. So, for project management, the PMP is fantastic for things that have a lot of processes. It’s just a terrific framework, but some companies have to work a little more agile. I mean, that really is where the name came from. There is a framework within project management called Agile and it’s for companies that are growth companies. It got really big during the technology boom where those companies were growing so quickly that they needed a faster way of being, a faster framework. And then Scrum is a technique within the Agile framework. It’s very confusing to explain it. 

So, these are project management. They’re almost like subtypes of how to do Project Management. What would be your recommendation to a small, mid-size, or large research site regarding project management?

For a small site, I would say that a person could take some classes or just read a book on project management or Lean Six Sigma. There’s a book called Execution that’s really good in terms of those things, but that might not be the person who’s “soup to nuts” for everything. That person might not have enough time or even the interest. It’s really about the director, the manager, or the owner of the site.   

Small sites have an owner, but many times they don’t have managers. So maybe for midsize companies, maybe it’s the manager who needs to do the project management training. What about a large research site? Should they actually invest in getting somebody who becomes a legit project manager?

I do think it’s the manager who needs to do the project management training for midsized sites.  For large sites, I think if you care about meeting your client’s needs for enrollment, quality, and timelines, then yes, larger sites should have someone who becomes a legit project manager. 

Yes, well said! So, if you care about meeting your client’s needs, then Dr. Senn says it’s essential to invest in project management.

Dr. Senn Says! 

Thanks for riding along!

Send me topics you want me to talk about at jeff.kingsley@centricityresearch.com!

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