Karen is the Head of Information Systems and Data Management (ISDM) for Exeter Clinical Trials Unit at the University of Exeter. The ISDM team consists of a Senior Data Manager who provides oversight across studies, multiple Data Specialists who lead on the build of our EDC systems, Data Managers who look after the ongoing data cleaning, and Data Management Support Officers who provide general DM support. We also work closely with Research IT who provide IT infrastructure support. All our trials are now run using REDCap, which we self-host on AWS.

Karen has a background in ensuring the successful and timely execution of clinical trials with over 10 years in the clinical trials industry, spanning both UKCRC-registered academic Clinical Trials Units and commercial Contract Research Organisations. 

Karen has experience in all stages of clinical trials, from start-up through to conduct/maintenance and finally closeout, consistently delivering clean interim/final data and completing database locks. Karen has particularly extensive experience in database design and build for study start-up, and also significant expertise in risk-based centralised monitoring. This experience spans clinical trials from Phase II to Phase IV, and has involved participant cohorts ranging from 80 to 5000. Karen's therapeutic experience includes 6 years in oncology and 6 years and counting in various other therapeutic areas and complex interventions.