Fiona advises on and implements global quality management system development and improvement projects to ensure that the clinical QMS keeps pace with the continually-evolving regulatory environment. At programme level, she works with clinical teams to develop risk and value-based initiatives which meet both quality and business objectives. Fiona conducts all types of GCP audits and am experienced in risk-based audit strategy planning on a global basis across a range of therapy areas, phases and molecule types.
Fiona is also a Certified Information Privacy Professional (Europe) with experience in working with controllers of special catergory personal data (clinical trial data). Recent projects have included working with companies to integrate data protection policies and processes into the clinical QMS and assessment of vendor capabitilty to process clinical trial data in accordance with the UK and EU GDPR.