Exploring Clinical Trial Management with Julia Boyd

In this episode of Clinical Research Career Conversations, Jo Merrifield chats with Julia Boyd, Senior Trial Manager at the Edinburgh Clinical Trials Unit, about the role of a trial manager. Julia discusses her career journey, the key responsibilities involved in managing clinical trials, and the skills needed to succeed in this field. If you’re curious about what a career in clinical trial management involves or how to get started, this episode offers helpful insights and advice. 

Transcript

Welcome to this episode of Clinical Research Career Conversations brought to you by Edinburgh Clinical Research Facility. My name is Jo Merrifield, and today I've had the pleasure of speaking to Julia Boyd, a Senior Trial Manager from the Edinburgh Clinical Trials Unit, about her role and career to date. I hope you enjoy.  

So hello. Today I'm with Julia Boyd. Thanks for joining me today. So this is a podcast looking at people's careers and opportunities within clinical research. I've mentioned you're a senior trial manager. Do you mind just explaining what trial management is? What does that mean?  

Yes, Jo, it's great to be here. So, I guess it's a very broad term that covers a lot of aspects of trial management. We help the Chief Investigator run the trial basically, because as you know they're very short of time. So there's a lot of tasks that need to be done throughout the study, you know, funding requirements, making sure you're running the trial according to sponsor SOPs, regulatory requirements. There's a lot of applications that need submitted before you can actually open a trial. So we take responsibility for that and we help support the chief investigator. 

So we work collaborating with a lot of teams throughout the trial - obviously with the chief investigator themselves, with the site teams, with any other departments like contracts, overseeing the budget, we work with the labs at site or the pharmacies at site, just whatever is needed.  

But it's often called a kind of jack of all trades master of none. So, you know, we don't have the expertise, we're not statisticians, we're not data managers, but we coordinate responses and get people involved. So there's a lot of tasks really, and I know people will be thinking, well, what exactly do you do? And I guess it varies depending on the type of trial, but also at the stage.  

So during setup, usually when we get involved right at the beginning, there's usually a sort of basic protocol written. So that might need a bit of revision. We can help get all the study paperwork together, the patient information sheets, any questionnaires, that sort of thing. We're involved in helping design the database and making sure that's reviewed by everybody, so we've got a functional database for collecting the data and we haven't forgotten anything. And yeah, again, just with contracts and any other aspects.  
 

So we're responsible for submitting ethics applications, applications to the MHRA, any Caldicott approvals, or any other approvals so that we're ready to start the study. And we obviously work very closely with the sponsor throughout and the monitors on the study.  

So that’s during study set up. We're involved right through the recruiting phase and follow up, and that's the time where we're opening sites because generally you don't get all sites … you know, you could be working on a multi-site trial with 30 sites and you're not going to get those all set up quickly. So you know, you start on one, it's usually the home site in Edinburgh here, and then gradually you'll open sites and it can be two or three a month, or faster than that. So that process can take, I mean, it can take a year and a half easily.  But once sites are open and recruiting, you know, we’ll help run meetings for the site, because that's really important to get the feedback from the research teams if there's any issues with finding patients or any difficulties with the database or their understanding of eligibility. We can help with that.  

And what else do we do? Just all the reporting requirements you need for a trial these days. Reporting recruitment figures every month. There's a lot of funder reports, just making sure they're getting reports when they need them, so we'll write the report and it'll be reviewed by the chief investigator.  And we organise meetings. It's a lot of… it's very collaborative. So we organise, usually internal trial management meetings, maybe every couple of weeks, investigating the core team. We organise the steering committee meetings and the data monitoring committee meetings that have oversight of the trial to make sure it's going ahead, and we have site calls with the sites every, you know, one or two months, newsletters to the sites just to sort of keep them motivated and deal with any issues.  

And then at the end of the study, it's all about making sure the data queries are all resolved by the sites, any QC checks are done so that we can get those resolved, and lock the database so it can be analysed. And we also are involved in the close down meetings for sites and the site initiation meetings - I forgot to mention that - and working with the sponsor and monitor, so we've got all these actions done so we can formally close the sites. And to a certain extent we're involved in reporting the… maybe not writing… contributing to the paper, but updating any protocol databases and things like that, registration.  

Wow, that sounds like a really kind of wide, varied role, juggling loads of balls I can imagine and making sure nothing drops. That's great. And your role as a senior trial manager, I'm guessing that means you've worked on quite a number of trials and things. What is the difference between a trial manager, senior trial manager?  
 

I think, well, I work in the Edinburgh Clinical Trials Unit and that's quite a large unit, so we've got about 25 staff and probably about around half my job, we manage our own trial, which is quite good because I wouldn't ever like to drop that, because I think it keeps your knowledge up to date and I enjoy that aspect of it. And the other half, we line manage, there's three senior trial managers, so we line manage about nine or ten people. And we do that and we also kind of oversee their projects as well. So if they've got any issues they maybe just want a bit of advice on, then we do that as well. So that's quite good. You've got a broad overview of quite a number of trials going on.  But that's, I mean, I've worked, I think I started in about 2008. That's what is it now, yeah, that's quite a long time, yeah.  
 

But I guess every trial is slightly different and things are always changing, so… 

Oh, it is, it is, yeah. The regulations have changed a huge amount in that time period. So you've just got to keep up-to-date with changes in GCP, but also there's a lot more approvals you need now before you start a study. You know, like data sharing and, you know, sharing tissues with lab samples and things, so it has expanded quite a bit, but it keeps you on your toes and you learn. You're never standing still, you learn a lot as you go through and your knowledge gets greater and greater, so yeah, it can be a fast-moving field.  

Yes, definitely. So what would a typical day look like? Is there such a thing?  

Well, I can answer this generally, but I think, as you've alluded to, a lot of our job, especially when the trial is recruiting, is helping support recruiting sites. And I think, you know, they often email us or phone us if they've queries just about eligibility of patients or any queries about study procedures. So obviously you have to be on hand and deal with these things quite urgently, because obviously there's a patient sitting opposite them and they're unsure if they're eligible. You have to answer that. So you can have plans for the day and they can be completely different because something comes up. So you have to be quite responsive to those things.  

But generally, keeping an eye on the study mailbox is a key thing. And there'll be certain tasks that you'll be doing. There's meetings, I mean, generally we have face to face meetings with the local team. Quite often all the other meetings are on teams now since COVID, which works quite well, I have to say, and it's often easier to organise, I think. So organising meetings, holding meetings, writing minutes from the meetings, and just, you know, there can be quite a lot of problem solving. It just depends on what's coming in. Because often I don't have the knowledge to solve the issue, but I'll know who can, so I'll be referring clinical queries onto the clinical team or stats queries onto the stats team or data management… you know, queries with the database onto data management. So I think it's just coordinating responses so that you can find the answer, yeah.  

So it's quite a lot of meetings and a lot of emails, but you do get to work on chunkier bits of work, like writing reports or writing a TSC or a funder report. So, you do get time to work on your own, on certain bigger tasks, yeah.  

And what would you say would be the most satisfying thing about your role? 

It's good if you are... if you're working on a study and you're lucky enough to see that study through - and some studies are very long, but the studies I generally work on are maybe three to four years - and to know that you've started that study, got it all the way through, it's recruited and you're finally seeing the results, is really satisfying because they can make a difference to patient care, make big changes for the better. So that's really good to see that.  

And I think sometimes, you know, day-to-day when you can have issues, you can have days where things just don't go well. It's important to keep that thought in your mind that you know why you're doing it.  

But there's a lot of pluses. I personally really enjoy that type of work - working collaboratively with people in the teams. And it's good, you know, I line-manage about nine or ten people and it's good to see them develop as well and bring them on. And then we can also have sort of projects of our own, like we're really trying to develop the training that we give people and use the experience within the trials unit to develop other people. So it's really good to see them come on and move through their career too, and gaining knowledge.  

But I know for other… I mean, I work in the trials unit - it's slightly different. In academia, there's… you know, you might be employed with a trials unit or it might be with a single chief investigator that employs their own trial manager and they might work on one or a small number of their studies. So, it depends where you're working, I think. And obviously there's trial managers in industry as well, which will be a completely different type of job.  

And if you were working individually with a chief investigator, is there still a network of trial managers that can help with support and things like that?  

Yes, yes. I think that's an important thing because I think you could maybe feel a wee bit on your own, but there is a network in Edinburgh, certainly for trial managers, and you've got a notice board that you can post questions to and get answers from other experienced trial managers.  
 

And do you mind me asking, so how did you become a trial manager? What's your story?  
 

I had a bit of a long route to get here, I guess. So I started off nursing, and then I got interested in research, but I went back to Uni and studied biology and then did my PhD and worked in a lab for a couple of years. And then when I was off with maternity, my maternity break, I had a good chance to have a think about, you know, sometimes I think when you have a break from things you think about where you'd like to work and see your career going.  

So although I enjoyed the lab, it's quite difficult to get funding, you know, continually as you get older as well, and I really wanted to do something that benefited people. And sometimes, well my research, although it went quite well, I didn't have any startling discoveries, and I thought clinical trials would be a really good area to work in, because you're using research that other people have done and ideas that other people have generated that have been funded to actually practice them in real life and run a trial and see if it is actually effective. So when I came back from maternity, I got a job with a commercial clinical trials company and I worked as a lab manager, a project lab, so it was a clinical trials lab manager really.  

So I worked with companies to run just the lab, you know, the blood testing and tissue testing part of it, and I did that for two or three years and then I got a job in the Edinburgh Clinical Trials Unit where I've worked ever since.  

So that's where I started off. So it was, yeah, I suppose it's just where it takes you. Sometimes you really enjoy a job but you think I need a change, but I want to work in a related field, you know, and it is a good… I've really enjoyed it in all the years I’ve worked there. And we have a lot of people coming through.  

And so obviously if you've had a nursing and then a lab background, is that necessary for a trial management role? Who could be a trial manager?  

It's not necessary at all. What we find, we do have people from nursing roles or people that have worked in a clinical research facility that move on to trial management. You should bear in mind that it's not… there's no patient contact in this role. So I know that some nurses might be interested but think actually I would miss patients too much and don't want to move away from that completely. But we do… probably the majority of people that come in to us now don't have any clinical… you know, they're not a nurse, or any medical training. And I think it'd be quite difficult to get a role as a trial manager without any previous experience, but I think in the trials unit we've got trial managers, we've got assistant trial managers, and we've got a kind of starting role which is a trial management support officer, and that's designed to get people in there, you know, their first job in trial management. And you know we've seen people work up to a senior trial manager that have started off in that role as they've gained experience and broadened their knowledge in the study. I think it would be quite difficult to get a job as a trial manager without any experience.  
 

I see, yes. But there's pathways there.
 

Yeah, there is. I mean, I think it's maybe easier in a trial management because it's just a bigger group of people, so there are more established pathways. But you know, even in commercial, quite difficult probably to get your first foot through the door, that is often the most difficult, I think. And you might have to... I know commercially, I was looking at taking a monitor's role when I first wanted to change into clinical trials because it was really difficult to get your foot in the door and I think it was easier for those type of roles, but it does involve quite a lot of travel, which did put me off a wee bit, yeah.  So there are definitely ways in, but you might not get a trial manager’s job right away, but you'd certainly get one that gave you the experience to be in a good position to get that.  
 

And what kind of skills or attributes would… yeah, if they wanted a role, what kind of things should they be good at or could bring to the role. 
 

I think that we work very much as a team, so we work closely with a large number of people from different groups - the research teams, the chief investigator - someone that enjoys team working, enjoys working collaboratively. I think someone that's a good communicator, like in meetings, but also, you know, in Britain a lot of it is by email these days, you know, and on the phone as well. So I think good communication is key. Someone who's really organised.  
 

I was going to say, surely... 
 

And remembering everything because there's so many different aspects to this role, but that's what keeps it interesting. And I'm a great one for to do lists and I have huge to do lists, but, you know, you’ve just got to prioritise and like this is what I'm going to try and do today and the rest can wait till another day. So you never get through your to do list, but at least I've got them there, so I'm not going to forget about them.  
Someone who enjoys problem solving. I think, you know, the sites, as they get forward in recruitment, have a lot of queries. They're not problems, but queries about things. Or they might want advice on, you know, this has been happening at our site. Have you got any suggestions to help this? And it might be that I personally don't have any suggestions, but I can say, well, at this site they have exactly the same thing and this is what they tried. So we gather knowledge from various sources to help solve things or if there's issues with recruitment, for instance.  

Proactive, did I say that? So proactive. I think that's a good one. So just trying to anticipate things before they happen so that they don't become an issue. And I think when you gain a bit more experience, you can maybe see down the line this might become a problem and head it off, you know, adapt things so that it doesn't. But I think someone that enjoys working in research, enjoys working with people, and is organised.  
 

Brilliant. It's been a great conversation, thank you so much. Just to wrap this up, do you have any tips that you could offer someone who's thinking about trial management role, or…?  
 

Yeah. What I would do is have a look at… go job hunting. So look for jobs anywhere in the UK and just look at the type of experience that they're looking for and the type of qualities and see if your experience sort of lends to that, or how you can, you know, take on new tasks to gain that experience so that you're in a good position when one comes along. And just keep your research quite broad, if you're looking, are you looking for… is it an academic role, it might be an NHS job, or it could be industry as well.  

So I think look in a lot of places for jobs, but do a bit of preparation and see, because they might be… you don't need any formal qualifications, especially not for academic jobs, so you don't need any project management qualifications or anything, but it's experience, I think that counts, and your knowledge.  
And even if you were able to, depends what role you're in, you know, if you were a nurse that would be able to get a bit involved, if there's a clinical trial going on in your unit, it would give you a lot more knowledge to go on, I think, increase your understanding so that when you went for a job interview I think you'd be able to be clear that you did have an understanding of what a clinical trial involved.  
 

And look at the, there's a UK TMN network - or trial managers network - that's really good. And it's got… they do advertise jobs on there, but they've got a lot of information about, you know, what a trial manager involves and lots of information that would be quite useful to look at.  

That's really great. I really like your tip about looking at… seeing what's out there and seeing how your skills kind of match and build on that. I think that's a really good tip for any role really, isn't it?  

Well, thank you so much, Julia, for your time today. It's been really interesting talking to you. Thank you very much.  

OK, thanks Jo.

I hope you enjoyed hearing from Julia today about the role of a trial manager. There are so many aspects to this central role, and it was really interesting to hear Julia's take on that. It was also great to hear tips she had for people who might be thinking about pursuing a career in trial management in the future. Thanks for listening, until next time.