I’ve been working here for 4 years and I am the Clinical Trial Manager for the renal cancer trials coordinated by the MRC Clinical Trials Unit. There are different aspects to my job – depending upon where the trial is, and whether it’s in set-up, open to recruitment or closed. During my time at the MRC Clinical Trials Unit, I’ve been fortunate to have had experience of working on trials at different stages.
At the moment I am working on the SORCE trial which will shortly open to recruitment. My tasks have included drafting the protocol with the Project team and clinicians, preparing submissions to regulatory and ethical bodies in order to allow the trial to run in the UK, helping to secure funding for the trial, designing the forms which will collect the clinical data on each patient, preparing patient information sheets, liaising with the drug companies involved with regards to the contracts to be drawn up, arranging meetings, dealing with serious adverse events and designing a database to ensure good data capture.
Whilst a trial is open I’m involved in the everyday management of the trial. I act as the first point of contact for hospitals. This can include answering queries about a patient’s eligibility to enter a trial, requests for trial protocols/associated documents and procedures for centre activation. My tasks also include drug supply management, arranging and being involved in monthly meetings with the Trial Management Group, document and version control management, trial promotion (this involves sending out newsletters, preparing posters, visits to hospitals to discuss the opening of a trial, dealing with queries/issues related to the study) and arranging Investigator meetings.
I’m also involved in the RE04 trial. This trial closed to recruitment in July 2006 and is in follow-up. I prepare annual reports to groups such as the National Cancer Research Institute, Trial Steering Committee and the RE04 Independent Data Monitoring Committee.
As a trial manager it is essential that I have excellent communication and organisational skills. It is helpful that I have cancer knowledge, but this isn’t essential. Probably the most important skill I have is that of project management, as I need to be able to work to timelines and deadlines, be able to delegate work and have good teamwork skills.
Ideally you need a degree in science to be a trial manager. I have a BSc in Biochemistry and an MSc in Molecular Medicine. After completing my Masters course I studied for a PhD in cancer tumour biology – although you don’t need a PhD to be a trial manager. Working at the MRC Clinical Trials Unit is my first job since completing my PhD.