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.
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!
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.
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.
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.
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.
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.
Good communications skills are a must, and you need to be confident enough to explain your thoughts.