Taking a PhD into Clinical Trials
By Sophia Donaldson, on 17 December 2018
Dr Mariam Al-Laith has a PhD in immunopharmacology from UCL, and is now a Clinical Trials Manager at King’s College London. Many PhDs speak to us about moving into clinical trials, so we asked Mariam to give us the lowdown on her role and how she got there.
Hi Mariam, what are you up to now?
I manage a large multi-site (30 hospitals in the UK, 3 in the Netherlands) CTIMP clinical trial. As part of the study we collect samples to analyse and store in a biobank, therefore the trial also involves five university labs. These labs are based in different areas of the country because the samples need to reach the lab within four hours of being taken from a patient. Part of my role is to coordinate all of the logistics.
Walk us through your journey from PhD to your current role.
After my PhD, I was awarded a one-year Royal Society fellowship which allowed me to conduct research in France, and this was then extended by 6 months with a French fellowship. When I came back to the UK, I was a post-doc for three years in the Department of Pharmacology at Cambridge. After that I started a family, and at that point gave up lab research. When I returned to work less than a year after having my first child, I took up a desk job as a Research Development Officer at UCL’s Department of Oncology. The role was part-time, three days a week, which worked well for me with my new family. After another break to have my second child, I moved into a Campus Manager role at the Whittington Hospital for UCL’s Medical School. I was in this post for seven years and then I worked for a year as an Executive Researcher for UCL’s Department of Speech and Language Therapy, all part time.
When I decided to start working full time again, I decided I also wanted to move into clinical trials. It was quite tough to get into because everyone was asking for experience. I had a lot of work experience of course, of management and research, as well as finance management, but none in clinical trials directly. It might have been easier to get in as a Trial Administrator or an Assistant Clinical Trial Manager, but because I had so much experience I wanted to go in at a more senior level. So, to upskill, I attended courses that were offered to staff at UCL about clinical trials and Good Clinical Practice (GCP). I made a lot of applications and eventually, helped by the extra courses as well as my experience in management, research, universities, and the hospital environment, I was luckily able to secure my current role. I have been in post for five years now. I joined the team from the start of the project, so I had to amend the protocol, submit the ethics and MHRA approval documents, and prepare all of the associated paperwork for running a multi-centre clinical trial.
What does an average day look like?
It’s very busy and varied, as I’m entirely responsible for all aspects of the trial management, including the finances. At the beginning of a trial there is a lot of documentation to prepare. Now as the trial is underway, I’m monitoring progress, making sure the data is clean, organising training sessions for sites to help them follow the protocol, liaising with people working on the trial, arranging for samples to be stored at the biobank, managing the trial medication and the randomisation system, documenting what is happening on the trial, writing reports for the Trial Steering Committee meetings, and managing the trial assistant and trial monitor. It’s never boring!
What are the best bits?
I like that the work is very varied. And the most rewarding part is when people come back to me and comment that the trial documents have been well written, that everything has been well run and explained, and that the sites have been well supported. People are appreciative of what I do, which feels very nice.
What are the downsides?
At times it can be overwhelming, so a good trial manager must keep calm. Sometimes people do the wrong thing over and over again, or College Finance Departments are under pressure and so they don’t process invoices for payment on time, making hospitals and other stakeholders complain because they haven’t been paid. All of that can be very frustrating, but you must keep a cool head.
Is a PhD required for this role?
It’s preferable for you to have a science background so you understand some of the terminology. A PhD is not required, but it does help you develop a range of skills, such as analytical and writing skills, writing documents, manuals, SOPs etc. – as well as a good understanding of how research works, which you need for this role. For these reasons, a PhD graduate can likely enter clinical trials work at a higher level, maybe an Assistant Trial Manager, than someone without a PhD, who may have to begin by processing samples for clinical trials in the lab.
Whether you have a PhD or not, you must be dedicated in this role, and you must have a good eye for detail. You have to be a careful reader, and be able to write very clear, logical, precise, accurate documents that people can follow. You have to submit a lot of documentation to various bodies, and the information you submit has to be accurate. A single small mistake, even just a typo, can lead to you having to revise and submit again.
Where do people tend to go if they move on from a Clinical Trials Manager role?
There are a lot of opportunities in the pharmaceutical industry, contract research organizations (CROs), university clinical departments, Clinical Trials Units, hospital Research and Development Departments etc. You could move on to a senior role, manage several trials, or manage a clinical trial unit.
What tips do you have for researchers wanting to move into Clinical Trials Management?
It’s a really good idea to learn more about clinical trials. There are loads of courses, and especially if you’re already in the university sector they should be easy to access. The first thing you should seek out is a Good Clinical Practice (GCP) session, for which you get a certificate. And ask to follow/shadow someone who is running a clinical trial. There are many people out there who are quite willing to mentor or at least have a one-off conversation to offer advice. And if you don’t feel you have enough experience yet to get in at the manager level, then try for an assistant level, or a sample processing or administrative role, and work your way up from there. You should also try to gain relevant experience while in your current role, such as project management, management of people, and finance management experience.