Women in Healthcare
Showcasing some of the brightest stars of pharma and healthcare
Why the interest in Clinical Data Management (CDM)?
It was the summer of 96 and I had just graduated in Biomedical Science and applied for my first job – described as “something to do with Clinical Research”. I was offered the job within hours of my interview. I was now a Clinical Data Assistant – whatever one of those was! I went on to learn that the role of CDM is to implement the right tools and processes to collect and manage data from clinical trials; checking that data is valid, consistent and complete to support statistical analysis. If the data isn’t ‘right’ the correct conclusions cannot be drawn, the trial is at risk of failure and the patients that have participated may have done so in vain. I will never meet these patients, but have a responsibility in their care and potentially their survival. I feel connected to them through the data. Unknowingly I had embarked on a challenging and ultimately fulfilling career that allowed me to put my science degree to good use, indulge my curiosity, push boundaries, develop and implement new technology-led processes and build teams of excellent data managers that share my passion to bring new, innovative treatments to more patients and improve or extend lives.
Where do you feel you have made the most impact in your role?
Historically CDM was considered very much a ‘back room’ activity. We were running paper-based trials and checking that the data was ‘right’ was manual and time-consuming with the risk of critical data being overlooked. There had to be a better way, and there was. Technology was advancing rapidly and with it, CDM. We were pioneers. First using fairly rudimentary tech to reduce manual data review and apply standardisation. Then leading the implementation of electronic Data Capture systems to streamline data collection and the adoption of advanced data analytics tools for focused, faster, more efficient data review. The clinical trial landscape is constantly evolving. I ensure that Bionical Emas data managers stay abreast of advances in technology and changes to the regulatory guidance, allowing them to be front and centre in the clinical team and recommend creative data solutions to our clients, using data and technology to drive key decision-making.
What traits do you value most in your team members?
To be curious, ask questions and challenge how/why things are done. Not everything comes with a manual – use your initiative and common sense to present solutions.
How do you manage a satisfactory work-life balance?
It has taken a long time for me to achieve this and there are no cut-and-paste solutions. I work from home so it can be hard to detach from work but I have trained myself how and when to switch off and, if I forget, my family are quick to remind me.
What advice would you give to those thinking of a similar career?
Be a lifelong learner. CDM is constantly evolving, studies are more complex, data sources have multiplied, technology has advanced exponentially and pressure to do everything faster has increased. Continuous learning will allow you to stay current, be flexible and adaptable to these changes and lead this evolution.