Since Ellen started working at Qserve, she wrote clinical evaluations for a coronary stent and class she monitored. Ellen have been involved in various gap analyses of clinical evaluations versus MEDDEV 2.7/1 rev 4, MDR gap.
The key expertise areas of Ellen
knowledge and execution of clinical trials/investigations at a global level
preparing/writing critical study documentation
collaboration with sites, sponsors and CROs
strategic thinking and change management
Ellen about working at Qserve
"What I like at Qserve is working on a diversity of projects with different types of medical devices. Also, I enjoy supporting clients in strategic thinking and operational management of clinical studies which are either prior to CE certification or post market clinical follow-up".
Ellen holds a PhD in cardiovascular biology and she has almost 20 years operational experience in conducting pharma studies in various indications (cardiovascular, neurology, nephrology, urology and orphan disease studies). Prior to Qserve, Ellen was a senior clinical study manager at Astellas and responsible for a global phase 3 nephrology study, and a global phase 2a urology study in a new indication.
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