Speaker 1: Hey everybody, welcome back to TheClinicalTrialsGuru.com, again it's TheClinicalTrialsGuru.com, thank you for visiting us amidst our renovations. We just bought a building, we just bought a building, a clinic for one of the sites and as you can tell, it was a complete teardown. For those of you following me on Snapchat, you see all the behind the scenes stuff, so make sure you add me there, Dan Sfera. I'm joined by Chris Sauber, he is one of my business partners for the consulting business, the SCS Equity and Investments. He is actually my only business partner for that consulting firm. And so today, we're going to answer a question from a viewer and by the way, for those of you that are new, welcome, thank you very much for watching, make sure you subscribe, you don't want to miss out, giveaways, right? You've gone with me when I've actually physically mailed people gifts. I have, a number of times. Number of times, right? So you don't want to miss out on that and the way this works is, you send your questions to Dan at TheClinicalTrialsGuru.com or you can call or text 949-415-6256, just like this person did today, right, and I'm pointing back there because that's where my phone is, I'm not a perv. So today's question comes from someone who texted us, what is a clinical research project manager and what is their role and responsibilities? So before we answer this question, we're going to assume it's a project manager within a CRO. You could have project managers at research sites, especially for some of the bigger research clinics, but we're going to answer this question, what is a project manager at a CRO? So Chris, would you like to?

Speaker 2: Thank you. Yeah, you're welcome. So, well, you'll probably have a little better idea than I do, but for starters, a project manager is going to oversee the CRAs, right? Yep, yep, yep.

Speaker 1: So they're the ones who choose the CRAs for a particular protocol. Project managers typically only work one study at a time, unless the study is relatively simple, then sometimes they can have more than one study. Project managers are the people at the CRO level that are organizing and delegating responsibilities to all the CRAs. Clinical data managers, those are the people that are going through the EDC data on a regular basis, scraping the data. You have the safety people from the sponsor and the medical monitors. The project manager coordinates all these individuals' activities, and a lot of you future CROs, or CRAs out there, sorry, might be interested to know that a project manager is the person who's ultimately in charge of hiring, normally, they're the ones in charge of hiring CRAs. They also play a role in selecting sites too, right? Yes. So project managers play a role in selecting sites. So the CRA may come to your site to do a site selection visit, but a project manager ultimately makes the call. Yes, we're going to go with this site, or no, we're not. Another interesting aspect is, and you just dealt with one today, they negotiate contracts and budgets, right? True.

Speaker 2: So what have your experiences been with the- Well, actually, I don't think necessarily all the time it's the project manager when it comes to a study, that it's the negotiator.

Speaker 1: Yeah, right, right, right, right. So they're not the negotiator, but they're the ones when the negotiator tells you, I need to go ask if this can be approved. That person that they're asking is the project manager, most of the time. And then if it's really in question, they'll have to go to the sponsor as well. Right, then the project manager needs to take that to the sponsor. So much like a site director at a research clinic is in charge of organizing and orchestrating all the staff members' activities and responsibilities when it comes to conducting clinical research studies, same thing at the CRO level with a project manager, right? So typically to be hired as a project manager, you need to start out as a CRA. To be hired as a CRA, you need some experience, typically as a coordinator. So if you're pretty ambitious, project managers make upwards of $150K per year, if not a lot more than that. However, their workload is ridiculous, they work like 80 hours a week.

Speaker 2: Plenty of room for advancement in this industry.

Speaker 1: Yeah, plenty of opportunities to climb the corporate ladder. If you are going to be a project manager and you're managing a global trial, be ready for midnight phone calls from sites in Europe. You're basically never able to be off the job, because your job as a project manager is to be on top of things as they occur in real time. So that's just the way it is, but you get paid very handsomely for it.

Speaker 2: I would assume, an analogy would be a project manager would be similar to a PI, in the sense that a project manager is responsible for most of everything that occurs in a study. The PI is responsible at site level.

Speaker 1: Yeah, true. And you can also compare medical monitors to the PI. They'll be the ones making the clinical decisions with the PI. And the project manager also coordinates the medical monitor's activities. So anyways, thank you guys for watching. That's what a project manager is in a nutshell. Their duties, their responsibilities, their role in the CROs. Thanks for watching. Dan and Chris from TheClinicalTrialsGuru.com. Take care.