Shilpi Sinha

Biography

A Clinical Research Professional with over 12 years’ experience, with 2 years as India lead in clinical operations with responsibilities of both functional and Line management, 8 years in Project & Quality Management and 4 years of clinical monitoring experience as a CRA in global multinational studies. International project experience in working & managing Oncology, Virology, Cardiology, Bipolar and Anti –Infective trials in India and across Central and Eastern Europe and South Africa; responsibilities have spanned the full duration studies, from start up to project close out. Managed Customers and Vendors in terms of development of contracts and MSAs and ensure contractual obligations are met, developed different geographies and successful in implementing metrics for tracking KPIs. Experience in managing the Kaizen events for Pharmacovigilance, Tracking of safety reports and responding to Health Authorities queries with PV team. Hands-on experience in clinical management while adhering to strict guidelines and processes; achieving benchmarks in clinical dispensing, improving processes and driven by a passion for achieving high quality at work.

Research Interest

Oncology, Virology, Cardiology, Bipolar and Anti –Infective trials