Quality Assurance Lead
I joined the Oncology Clinical Trials Office (OCTO) in early 2020 after spending nearly 10 years working in the R&D office of Oxford University Hospitals NHS Foundation Trust. Prior to that I worked in a major pharmaceutical company for 9 years.
As Quality Assurance Lead, my role is quite diverse. Overall I am expected to ensure that appropriate quality management systems are in place to support efficient and compliant delivery of the OCTO portfolio of clinical trials. The role requires working closely with the OCTRU Head of Regulatory Affairs and Quality Assurance to ensure that the OCTRU quality system and procedures are appropriate for the OCTO Portfolio. The role helps to assess the ongoing suitability of systems, identifying and implementing changes through trial specific or process reviews where these are required e.g. as a result of changes in working practice, audit findings or changes to regulatory requirements. I also assist in site monitoring or audit processes and investigation of quality related issues at trial sites and associated third parties e.g laboratories involved in trial sample analysis. I also review trial documentation such as risk assessments, data and central monitoring plans to ensure appropriate mitigations are in place for GCP compliant trials.