Emily, Trial Manager

Working on various infections trials

I have been working at the CTU for 5 years, initially as a Data Manager and after 2 years progressing to my current role as a Trial Manager. I have worked on various infections trials since joining the unit, in disease areas such as HIV, influenza and hepatitis.

I work alongside the Data Managers on the day-to-day running of the trial.

I am currently the Trial Manager on STOP-HCV-1, a trial investigating treatment optimisation for hepatitis C. The trial has just closed to recruitment, but I have worked on it since opening. My day-to-day tasks have varied depending on the stage of the trial.

During trial set-up, a typical day might have included designing CRFs, working with Data Services to develop the database, writing procedures on monitoring, safety and drug management, submissions to ethical and regulatory bodies, or writing procedure manuals and training slides for sites.

Following the start of recruitment, I had frequent contact with the staff based at hospital sites, answering their queries, obtaining updates on recruitment, reviewing eligibility and randomising participants on to the trial. I prepared and submitted amendments to ethics and regulatory bodies, which might include updating the protocol, patient information sheet or participant materials.

Throughout the whole span of the trial, I work alongside the Data Managers on the day-to day running of the trial and meet regularly with the Trial Management Group which includes the trial statisticians, clinicians and project manager. I am required to write annual reports for ethics and the regulatory body and ensure all trial procedures are kept up to date with any updates to the protocol or unit SOPs.

Opportunities to get involved outside day-to-day work

There are several opportunities to be involved in activities and committees outside of the day-to-day work on trials. I am secretary for the Quality Management Advisory Group and have been involved in writing and reviewing unit SOPs.

Having background knowledge of science is extremely useful as a Trial Manager. I have a BSc in Human Biosciences which has provided me with more than adequate knowledge for this role. Following university I also worked for a while in care settings and a hospital before starting at the CTU. This was also useful as it gave me an understanding of the healthcare system in the UK, as well as developing my team work and communication skills, both necessary for working as a Trial Manager. Of most importance however, is organisational and project management skills. It is essential to be able to adequately manage your workload, meet deadlines, and balance and prioritise several tasks that may be ongoing at once.

As a Trial Manager, there is the potential to progress within the CTU to a Clinical Project Manager. The skills you gain here, such as project management, organisational and communication skills are also transferrable to other roles both within research and in other fields.