Innovative and results-focused clinical project manager with 15+ years of healthcare experience, and a demonstrated ability to lead clinical operations. Professional history emphasizes the importance of effective people management skills and communication, as well as quality data. Even-tempered and persuasive nature allows to easily negotiate.
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Drug dev. process, ICH/FDA regulations; Trial design/protocol; EC/IRB; IP pipeline; GCP; Data analysis/reporting; Monitoring; Closeout.
Risk based monitoring; FDA/European regulations; EMA, CTA, Eudract; Philosophy of science; Pharmacoeconomics.
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