Head of Quality Assurance and Regulatory Affairs
I have over 20 years experience of working in a clinical trials environment, with 16 years of this specialising in Quality Assurance and Regulatory Affairs. I have worked on a wide range of trials and studies including commercial phase 1 healthy volunteer trials and non-commercial phase I, II, and III trials in patients.
I currently lead and manage the Quality Assurance and Regulatory Affairs Team at the Centre for Trials Research as the Head of Quality Assurance and Regulatory Affairs. I lead a team of 9 quality assurance and regulatory affairs staff including the centre's central pharamcovigilance and safety reporting team. I also chair the UKCRC QA Operations Group and work nationally to facilitate the sharing of best practice.
I lead the Centre's Equality, Diversity and Inclusivity group, reporting to the School of Medicine EDI. I am the Centre's EDI protected characteristic lead for gender reassignment. The role of the protected characteristic lead is to ensure that we appropriately consider our obligations under the Equality Act and to maximise equality and diversity in our decision making.
Head of Quality Assurance and Regulatory Affairs (2015-present)
Centre for Trials Research
Quality Assurance Manager (2009-2015)
Wales Cancer Trials Unit
Senior Quality Assurance Officer (2007-2009)
Simbec Research Ltd (Phase 1 healthy volunteer trials)
Quality Assurance Officer (2005-2007)
Simbec Research Ltd
Research Assistant (2005)
Simbec Research Ltd
Research Technician (2001-2005)
Common Cold Centre (Phase 3 patient trials)
Honours and awards
Cardiff University Outstanding Contribution Award (2018)
I am interested in early phase research, and novel trial designs.
I am the centre's study lead for TRIAGE-SAE, a study that aims to assess the feasibility of text mining in the analysis of text narratives in serious adverse event reports to identify trends and potential safety signals. Data was collected from 6 ongoing clinical trials at the Centre for Trials Research and psuedo anonymised at the point of extraction from the system. The narrative sections of the SAE reports were transcribed and annotated by 2 independent annotators and compared to the automated coding via text mining. The results and conclusions are in the process of being submitted for publication (April 2021).
I am a member of the advisory board for the PrinciPILs study, which is looking at developing and testing participant Information leaflets (PILs) that inform and do not cause harm ("nocebo effect").