Description
My strong technical experience and education will make me a very competitive candidate for BA/BE study expert. The key strengths that I possess for success in this position include: • Total experience of 11 years in clinical research. Currently Heading Clinical Department for BA/BE and Trials. • Clinical Study planning & scheduling, follow up & tracking, problem solving for all clinical studies / clinical projects • Sponsor communication for clinical study update and Inter department co-ordination and routine update • Faced various regulatory inspection like DCG(I), US FDA, MHRA, AFSSAPS., WHO. • More than 700 BA/BE studies managed during carrier. • Around 10 Clinical trials managed [includes studies on Diabetes, Oncology, Osteoarthritis, ] • Regulatory Application to DCGI, application for export NOC, IBN for narcotic products for BA/BE and Clinical trials • Ethics Committee submission
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