CAREER SUMMARY * Knowledge of Medical terminology. * Qualitative experience in clinical trial monitoring, data management, writing protocols and designing case report form. * An out of box thinker with excellent team management skills. Able to work under optimal supervision and in a matrix environment. * An effective communicator with exceptional relationship management skills with hands on experience in networking with project partners and allied agencies. * Well versed in ICH, GCP, FDA, CDSCO and applicable regulatory/health authorities. * Proficiency in Empower, Microsoft Office word, Excel, Power Point. AREAS OF EXPERTISE * Clinical Research, QC, Project Coordination, Pharmacy Management. * Regulatory Compliance / Audit, Training & Development.
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