Responsible for coordinating full length pharmaceutical trials, from Preclinical through study completion. This included responsibility for ensuring that clinical procedures were performed per protocol requirements and in accordance with FDA, ICH/GCP, Sop鈥檚 and IRB guidelines. Other responsibilities included regulatory document submission/updates, IRB submissions, and serving as a liaison between study participants, investigators and sponsors.
Responsible for Clinical Business Development across globe working in multiple therapeutic indications from Phase II 鈥� IV. Extensive global and therapeutic knowledge of clinical study process and requirements; Management of Confidential agreements...
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