Who is PHARMExcel’s Head of Clinical Operations, what do they do, and what experience does it take to get there?
We sat down with Margaret Irwin, PHARMExcel’s Head of Clinical Operations to find out more about her journey before PHARMExcel, what her role entails, and what she’s most proud of.
Over 30 years of experience leading clinical operations
Margaret started her career in haematology and moved into clinical research in 1992. Whilst working, she achieved a BSc in Bioscience and Health. Leading clinical and technical teams in complex, technical FTIM Phase I trials at Covance CRU Leeds, Margaret was instrumental in the unit’s first MHRA inspection under the accreditation scheme, as well as being involved in validation for a brand-new aseptic Pharmacy and Human Appetite Lab, located on site.
Margaret’s next role was Head of Clinical Operations in a Site Management Organisations. Her speciality was Dementia, pain, and Diabetes, and she covered 5 clinics in the North of England. She then moved on to Quintiles as their Director of Clinical Operations, although she initially worked as Programme Director, partnering with a sponsor, and covering Oncology, Cardiovascular, and Infectious Diseases in all phases and therapeutic areas.
Margaret then spent 5 years at UBC Late Stage Ltd as Director of Clinical Site Services Europe, responsible for all the site management and monitoring activities across EU and ROW, before joining PHARMExcel in 2020.
Achievements at PHARMExcel
Margaret’s role at PHARMExcel is to oversee all the CRO operational activities at PHARMExcel, this includes all the staff and all the clinical trials, and working closely with the CEO, Yvanne Enever, on business development. Margaret is also part of the Executive Leadership Team (ELT), so she also looks at the strategic direction of PHARMExcel.
Margaret credits the fantastic team at PHARMExcel for many of the company’s achievements, such as its ISO 9001 certification. She is also proud of the significant trials that PHARMExcel has been involved with. During the COVID-19 pandemic, PHARMExcel was the chosen CRO for a booster vaccine study, called COVBOOST. This was a world first, pivotal trial that helped shape UK policy recommendations for future protection against COVID-19. Margaret believes that the team involvement, working around the clock to tight deadlines highlights their dedication to PHARMExcel and the clinical research we are involved in.
Looking at the lifesciences industry
Margaret sees the innovation potential as an exciting part of working in clinical research. Targeting life changing illnesses and diseases, including some that most people have never heard of brings a real depth to this industry, and the influence of working alongside people who really care about their job and what they do is a fundamentally positive part of this role. She believes that even though PHARMExcel’s role is a small part of the process, it is incredibly impactful and has the potential to change many lives.
It is not without its challenges, however. The ramifications of leaving the EU have made setting up and running trials more complex with changing regulations. Margaret also noted the how the pandemic brought many challenges, as well as impact of the UK government reducing funding for research.
Keeping it positive
One of the questions we asked Margaret was what she likes the most about working at PHARMExcel, and she had plenty to talk about!
Her first answer was the people. Margaret appreciates all the people she works with and believes the ethos of the company – openness and transparency – are core values she appreciates. She also appreciates that she is involved with the innovative ideas and concepts that make up PHARMExcel, something that she wouldn’t necessarily be part of if she were in a bigger, less personal CRO.
