Ellen van Kleef, PhD
Ellen holds 20 years of experience in pharmaceutical- and medical device industries in clinical operational management as study manager. Ellen has extensive experience in conducting global clinical studies at an operational, as well as a scientific expertise level. Through these years she worked at different companies with European headquarters for clinical development in the Netherlands, including manufacturers of “drug-device” combination products. She has experience conducting studies in various indications, being cardiovascular, neurology, nephrology, urology and orphan disease studies.
In that perspective the following skills are considered critical: knowledge and execution of clinical trials/investigations at a global level, preparing/writing critical study
documentation, collaboration with sites, sponsors and CROs, project management, strategic thinking and change management, problem solving. Prior to Qserve, Ellen was senior clinical study manager at Astellas and was responsible for a global phase 3 nephrology study, and a global phase 2a urology study in a new indication.
Ellen combines strong experience in clinical development, quality and regulatory with a pragmatic, result driven approach at both operational and scientific level.