Andrea Cradduck-Bamford
Quality Assurance Manager
Andrea has worked at the Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU) since 2014. First as a Trial Manager and now as the QA Manager, assisting in the development of risk-based, flexible approaches to QA.
Andrea's role includes overseeing the development of the Quality Management System, management of incidents within studies and the resulting corrective and preventative actions. She is also the lead for preparing for audits from external parties and regulatory inspections.
In collaboration with trial management and clinician colleagues, the QA function performs internal audits, assists with development of Standard Operating Procedures and identifying potential risks for mitigation during trial set up and conduct.
She has worked in clinical trials for 19 years working in various roles from data management, trial management, monitoring and pharmacovigilance. During this time she has managed and mentored multiple staff in various functions.
Throughout the years, Andrea has been successfully delivering trials with significant impacts on government policy regarding population health, redeveloping the safety reporting process and monitoring practices in a previous role, and is a veteran of multiple successful inspections from various regulatory bodies including the MHRA and FDA.