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Emma Plested is a Programme and Regulatory Affairs Director (UK) for the Oxford Vaccine Group, Department of Paediatrics. Emma describes her career to date, what a typical week looks like and what she is working on at present.

Number of years in clinical trial management

11 years in clinical trials management, 18 years in clinical trial administration.

How did you get here?

I began my career in childcare as a nursery nurse. I then joined the Oxford Vaccine Group (OVG) as a Play/ Study Assistant in 2005. After joining OVG I progressed through various roles within the group, moving to Clinical Trial Assistant, Clinical Trials Coordinator, Project Manager and then Senior Programme Manager and Regulatory Lead. In 2021 I was appointed as Programme and Regulatory Affairs Director.

What are you working on at present?

My role now is focussed on the oversight of the full OVG UK portfolio of over 40 trials, leading and developing a team of Senior Project Managers, Project Managers, Junior Project Managers and Trial Administrators, to ensure successful delivery. I also develop training programmes for the wider multidisciplinary team, to teach them the fundamentals of delivering clinical trials.

Throughout my time at OVG I have worked on over 120 CTIMPs (Clinical Trial of an Investigational Medicinal Product) of new or improved vaccines and 7 CHIM (Controlled Human Infection Model) studies, in various roles as above. The Clinical Trial Coordinator, Project Manager and Senior Programme Manager roles all required me to manage multiple trials/CHIMs at any one time, ensuring it was delivered to time, within budget and to high standard of quality. Since 2018 I have also been involved in the set up and delivery of several large multicentre CTIMPs, some of which paved the way for the expedited delivery of the Covid-19 vaccine trials, by having established networks and processes in place.

My biggest achievements have been the project/operational management of a series of Covid-19 vaccine trials, including for the development of the Oxford/Astra Zeneca Covid-19 vaccine, from phase 1 through to licensure. More recently the programme/operational management of a series of heterologous and homologous Covid-19 vaccine multicentre trials. These trials were to provide data to the UK Government (Vaccine Task Force and the and Joint Committee on Vaccination and Immunisation) and Global partners (CEPI) to inform decision makers to be able to rapidly change policy in the race against the pandemic.

What education/qualifications do you have?

I do not have a degree level qualification. I have childcare qualifications from my time as a nursery nurse.

While in post at OVG I have undertaken several training opportunities and an apprenticeship to obtain some further qualifications. These include project management qualifications and an Oxford Brookes University Masters Module in Clinical Trials Planning and Management.

What skills or attributes are most valuable in your role?

Organisation, initiative, flexibility, forward thinking, leadership, financial understanding, being self-driven, an eye for detail, regulatory and operational knowledge.

What advice would you give to someone who wants to work in trial management?

Do it! It can be fast paced and challenging but it’s incredibly rewarding and can have a huge impact on world health. There is a lot of training material and information available online to build your skillset and understanding. If you are new to clinical trials consider applying for one of the junior/assistant trial management postions (Junior Project Manager in our case at OVG), as these can come with training and support to allow you the opportunity to develop your skills before becoming responsible for larger or more complex trials.

Why should someone come and work in Oxford?

The impact Oxford has is so far reaching. Oxford was at the centre of much of the Covid-19 pandemic research – in preventions and treatments. It has a great support network in research services with many high impact multidisciplinary research groups to consider depending on your area of interest.