Author: Louise Stanley

Sarah Manney is Deputy Head of Research Governance and Quality Assurance Lead at University Hospitals Birmingham, and is the Trust’s first recipient of the BHP People award.

We spoke to Sarah about her journey from clinical researcher to audits and governance, navigating Trust mergers and a global pandemic, and the sheer scale of clinical trials at UHB.

Q: Can you briefly run us through your career so far and how you came to work at UHB?

SM: I always wanted to be a research scientist, and I was fortunate to follow that path early on. I joined what was then Heart of England NHS Foundation Trust in 2000 as an air pollution scientist, which was always an interesting job title to explain.

My work focused on researching how air pollution affects people with conditions such as heart and lung disease, including asthma and COPD. I also ran a couple of research laboratories, including an exposure lab, where we worked closely with patients and got to know them very well. That was a fantastic foundation for my career because it combined science with direct patient impact.

While working there, I completed my PhD in 2008 and later moved into respiratory research, specialising in severe asthma for a number of years. As a registered clinical scientist, my role involved both research and patient-facing assessments.

I then worked across a range of specialties, including prostate cancer, gynaecology and ENT, before moving into quality assurance in 2013.

That background in clinical research and trial delivery gave me a strong foundation for the role. I started as a team of one, and we’ve since grown into an expanding team with responsibility for quality assurance across the Trust.

So, it’s been a varied journey, but one that’s always stayed rooted in research and improving standards and patient care.

Q: What are some of the tasks and duties you’re involved in most frequently within quality assurance?

SM: A large part of our day-to-day work is audits and monitoring. Audits provide a snapshot of a study at a specific point in time, while monitoring is an ongoing process. We monitor Trust-sponsored studies and audit externally hosted or sponsored research.

This involves reviewing trial documentation such as medical records, investigator site files, pharmacy and radiology records to make sure studies can be fully evidenced and are being run correctly. Everything we do is guided by Good Clinical Practice standards to ensure research is safe, ethical and high quality.

Alongside audits and monitoring, we also handle a significant amount of query resolution. A few years ago, we introduced a shared inbox to make it easier for colleagues to contact us. Historically, some people were hesitant to approach quality assurance teams because they assumed we were there to find fault. In reality, our role is to support people and help them get things right.

That change in approach has made a big difference. We used to receive one or two emails, and now we receive dozens each week. A lot of our time is spent answering questions, solving problems and helping teams work through issues quickly.

We also have a strong reporting process, including peer review, which helps staff develop both their technical knowledge and their report writing skills.

Another key part of my own role is leading investigations into more significant incidents or issues, where experience in trial delivery is particularly valuable. Everyone in the team has practical research experience, which means we can bring that real-world understanding into our quality assurance work.

Q: You’ve implemented a number of processes and systems to improve workflow – can you tell us a little more about these and the impact they’ve had?

SM: We’ve focused on improving both processes and systems to make quality assurance more proactive. One key change has been introducing support at study set-up stage, so we work with teams from the very beginning on documentation, training and requirements. That helps prevent issues later and gives staff the right support early on.

We’ve also introduced a self-monitoring checklist that teams can use themselves. This helps colleagues understand what auditors and regulators look for, while encouraging greater ownership and confidence.

On the systems side, we’ve developed electronic tools to track audits, activity and findings. That allows us to identify trends, spot where extra support may be needed, and tailor training for specific teams or investigators. We deliver training sessions linked to quality assurance, governance and research standards more broadly, helping colleagues build confidence and maintain high standards across the organisation.

Similarly, we are also developing tools to track our electronic incident reports, including safety reporting, which helps us respond more quickly to emerging issues and areas of potential risk.

Q: What changes have you seen in clinical research throughout your career and what developments can you see on the horizon?

SM: The scale of change has been huge. Organisationally, the merger of Heart of England and UHB significantly expanded the scope of our work and gave us the opportunity to grow the quality assurance function. During the COVID-19 pandemic, despite the immense challenges across healthcare, there was also a need to move at pace and adapt quickly, which accelerated some improvements in how research was delivered and supported.

In clinical research more broadly, one of the biggest transformations has been in HIV treatment. Earlier in my career, outcomes were far more limited, whereas now many patients can live long and healthy lives with effective treatment.

Another major development has been the rise of biologic therapies. I saw that particularly in respiratory medicine, where treatment options for severe asthma have expanded enormously, and similar progress has been seen in cancer care and other specialties.

Looking ahead, personalised medicine is one of the most exciting areas. Treatments are becoming increasingly tailored to the individual patient, particularly in areas such as cancer, and I think we’ll continue to see major advances there.

One of the privileges of this role is having visibility across many specialties, so you get to see not only the innovation itself, but the real difference it makes to patients’ lives.

Q: What’s something patients might not realise about research studies at UHB?

SM: I think many patients are surprised by the sheer scale of research taking place at UHB. We have more than 1,500 studies open at any one time, either recruiting participants or following patients up.

People also often associate research mainly with cancer, but in reality we now have studies taking place across almost every specialty and disease area. Whatever treatment pathway a patient is following, there is likely to be some form of research connected to it.

Our long-term ambition is to be able to offer research opportunities to every patient who comes through our doors.

Q: What advice would you give to someone considering a career in research governance and support?

SM: My main advice would be to take your time and focus on learning. It can be tempting to think immediately about progression, but research is a field where experience really matters. There is a lot you can learn through training, but much of it comes from doing the role, working with different teams and understanding how all the moving parts fit together.

It’s important to stay open-minded and learn from others, no matter how much experience you already have. Research is constantly evolving, and everyone is still learning all the time.

You also need to be able to balance working within strict regulations and frameworks while remaining practical and solution-focused in the real world.

Above all, remember that patients are at the centre of everything we do. Whether you’re approving a study, carrying out an audit or supporting delivery behind the scenes, the ultimate purpose is always to improve outcomes for patients.