Senior Director Clinical Operations
Karen joins Aceragen as Senior Director Clinical Operations. She has over 25 years working experience in global CROs, pharma and biotech companies. She brings valuable set of experience in clinical operations, project and quality management. Karen was instrumental in successfully creating and growing the Early Phase Monitoring Department of a global CRO, where she served several years as European Head. She was the main point of contact for regional quality escalations, CAPA resolution, and was responsible for developing and implementing KPIs for the early phase clinical operations department. Over the last 15 years she is focussing on early phase studies. The most recent years she is working in the field of rare orphan Lysosomal Storage Diseases, including Farber disease, where she oversaw the conduct of Natural History and First in Human Studies from conception to study closeout. After finishing her education as Pharmacy Technician in Germany, Karen obtained a Master of Science in Clinical Research from the University of Wales in Cardiff, UK.