Clinical Research Project Manager

Kate

Clinical Research Project Manager

It’s often hard to find that first position, but persevere. Kate

What ​​do you do?

I work in the clinical research ​​department of the UK arm of an international pharmaceutical company. My department manages the UK and Ireland’s involvement in the company’s global trials, or trials purely placed within the UK e.g. a phase I study in healthy volunteers.

My role involves assessing the feasibility of a trial protocol for the UK and Ireland, finding suitable investigators and trial ​​​sites and determining the number of patients the UK/Ireland will be able to contribute, gaining ethics and MHRA approval, and managing the trial all the way through set-up, the recruitment phase and to its’ completion. I’m typically responsible for the management of 5-6 trials.

What does your typical day involve?

The tasks vary depending on the stages of the trials and whether the trial monitoring is out-sourced to a contract research organisation (CRO). For example I might be visiting an investigator and his team to discuss trial feasibility or be accompanying a Clinical Research Associate (CRA) on a monitoring visit to evaluate the trial management. Or, in the office I might be completing paperwork for an ethics submission or a substantial protocol amendment. I might also be reviewing monitoring visit reports or be preparing for a team meeting with the CRAs to discuss trial and investigator site status. I’m also responsible for ensuring the trial master file (essential paperwork) is up to date with the support of our trial administrators, and updating various e-tools used to manage and track all aspects of our trials. I also spend part of my day resolving questions from our trial sites, CRAs, CROs and responding to questions from my headquarter colleagues. My responsibilities also include organising national investigator meetings at the beginning or during a study. The tasks are varied and numerous!

Do you work mostly on your own or as part of team?

It’s both. In the office I’m usually working on my own, but I liaise with CRAs, administrators, fellow project managers, our director, my colleagues at our HQ and of course with the doctors, nurses and pharmacists working at the sites where our trials are taking place.

How long have you been in your current role?

I’ve been in my current role for 8 years. I enjoy the scope of the Clinical Project Manager role and have been fortunate to work on many different trials (phase I, II and III) with different products and in different indication areas.

What qualifications and experience do you have?

My A levels were Biology, Chemistry and Maths. I went to University in Bradford, where I studied for a degree in Biomedical Science, which involved a year out gaining work experience. After my degree I was keen to put my degree to practical use and started work with the Blood Transfusion Service in a tissue typing lab. After a while I was drawn back to research and found a job working as a research assistant for a consultant rheumatologist at the John Radcliffe Hospital in Oxford. After this I returned to academia and did my PhD at King’s College in London in the field of autoimmunity.

When and why did you decide on a career in the pharmaceutical industry?

It was at the end of my PhD. I looked ahead and realised a long-term career in academia wasn’t for me. I’m grateful to a colleague in my research lab who mentioned the CRA role.

How has your career developed since you left school, college or university?

My first role was in a contract position in data management in a pharmaceutical company. It was great to experience this. Fortunately I was able to move on to being the CRA on the same study and found myself visiting lots of GPs around Glasgow which was quite a contrast to working in a lab! I then moved to a permanent CRA role in a new company and here progressed to become a senior CRA and then a clinical research manager. After 7 years I decided to move again and took up my present position as a project manager.

Do you think additional qualifications or experience would be an advantage for someone entering the industry now? What might be valuable?

A relevant degree is essential and depending on the role some companies value a PhD. The commonest pathway to being a project manager is to first gain experience as a CRA.

What is it like socially where you work?

It’s a friendly and supportive team. We have coffee breaks and lunch together and occasional pub lunches to celebrate birthdays and milestones. The company has a social events committee that organise various activities throughout the year.

What are you most proud of in your career?

Achieving my PhD and developing my career in the pharmaceutical sector.

What possibilities are there for your career in the future?

There are many possibilities within the industry. Many project managers head for roles involving international project management where they are more involved in overseeing the trial across all participating countries.

What do you think are the most important skills for someone in your role to have?

Good communication and presentation skills are key as the role involves discussing products and protocols with key opinion leaders in the disease areas you work in. Clearly project management skills are also important, recruitment targets and timelines need to be met! A willingness to travel is also essential.

What is the one piece of advice you would give to someone seeking a career in the pharmaceutical industry?

We usually like to find some prior experience and for that reason it’s often hard to find that first position, but persevere. Use a recruitment agency to help you. Don’t be afraid to start in a role that might not be exactly what you want initially. Often once you are in an organisation opportunities will arise.