Stephanie Levy

Number of years in clinical trial management:

7 years in clinical trial management - (14 years in clinical trials)

How did you get here?

I studied a BSc (Hons) Human Psychology at Aston University. I wanted to be a Psychologist, and to do so we were advised to get some research experience. I enjoyed it so much, I never left.

After graduating I went on to work in patient facing research roles in the NHS & University setting, including:

• Research Assistant for a Phase 1 NHS trial exploring the use of ketamine as a treatment for depression.
• Clinical Researcher conducting research in dermatology, hepatology, gastroenterology, diabetes, cardiology, stroke, Parkinson’s Disease, cancer, rheumatology, elderly care, orthopaedics and ENT trials (approx. 40 trials).
• Research Associate for 2 academic trials exploring the semantic knowledge of words & quality of life of patients with Huntington’s disease.

Some of these roles included working directly with Chief Investigators to design research, or working closely with Principal Investigator at site. Often the trial teams were very small which meant I gained more hands-on varied experience. This included designing the eTMF, making regulatory submissions, conducting participant clinic and home visits (screening, consenting, follow up), collecting and entering CRF data, blood collection and processing, and presenting the trial to colleagues in the community to encourage referrals. Trials varied from straight forward observational studies to very complex commercial early phase CTIMPs.

This knowledge was all useful when moving to trial management, particularly when designing trials, training sites & answering queries. I also feel my experience and enjoyment of juggling multiple trials at once in an acute setting as a Clinical Researcher, set me up well for the Portfolio Lead role. I joined OCTO as a Trial Manager, working on 2 trials in oesophageal cancer and 1 in pancreatic cancer. After 3 years as a Trial Manager I moved to the Portfolio Lead position.

What are you working on just now?

Currently I manage a Portfolio of 9 trials. These are primarily managed by Trial Managers, Clinical Trial Administrators and Clinical Trial Support Officers. I provide senior oversight of the trials and line management of the team, in a similar role to a Senior Trial Manager. I’m also involved in the review and set up of new trials prior to funding being approved. 

What do you do in a typical day/week? 

A typical week will involve 1:1 catch ups with the Trial Managers in my team on their trials. This often includes troubleshooting any issues and looking at the overall delivery of the trial to time and target. I will also step in where more senior support is needed, or escalate problems we are seeing across the trials. There will often be further unexpected trial events through the week which I will contribute to. I often attend or chair meetings providing senior oversight and guidance, this might be with trial statisticians, the data team, site contacts, commercial funders, lab teams, Trial Management Groups. There may also be review and planning meetings with the senior team, finance, and contracts. I often have trial specific or OCTO wide documents or processes to write, review or approve. I may also be covering for any gaps in the team to keep the trials running smoothly. My week often involves some element of staffing/team planning/HR work, whether that’s reviewing appraisals, being involved in interview panels, or generally ensuring all is well in the team.

What education/qualifications do you have?

BSc (Hons) Human Psychology

What skills or attributes are most valuable in your role?

Other than the obvious experience in clinical trials I’d say critical attention to detail whilst also seeing the wider picture, ability to juggle and switch between multiple tasks at once, keeping a level head, being approachable, a good manager and collaborative.

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

Do it! Ideally start off in a role where you can get as much varied experience and exposure to different parts of the trials process as you can. Whether that’s shadowing, or observing how different teams work. For example, this could be gained from taking minutes in meetings. You don’t need to know everything, but you must ensure you don’t make any assumptions to work safely, and know to ask/escalate when needed or know where to look for advice.

Why should someone come and work in Oxford?

For me, I like that the trials are of a high standard, with clear regulatory compliant processes laid out as part of the wider clinical trials research unit. We get to work in cutting edge areas with some very novel ideas and designs with some of the leading experts in the field. I have always found the ability to work with multiple different professions and collaborators that contribute to a trial very interesting and enjoyable, particularly with statistics and patients and public involvement and engagement (PPIE). Also, the people are lovely, this honestly remains a big influencing factor for me; it’s a very welcoming group with so much skill and valued diversity in experience! There are also many training opportunities, along with support and encouragement if you wish to progress your career further.