Nareshkumar Narayanwal

Background

About Nareshkumar Narayanwal

Work Experience Summary: • More than 20 years of exposure in clinical research and drug development, • Global and Local Clinical and Project Management Experience > 12 years, approx. • Managed different phases and types of clinical studies at CRO (29) and Sponsor (16). • Experience in handling (from the Sponsor end and the CRO end) global and regional studies across the globe involving: Asia-Pacific, Africa, Middle East Africa, Europe & and North America. • Involved and managed a total of 45 Clinical studies (multi-country, multi-centric) of various therapeutics areas (Anti-infective, Endocrinology, GI, Gynecology, Hormone Replacement Therapy, Nephrology, Neurology, Oncology, Ophthalmology, Psychiatry, Pulmonology, Rare Diseases, Respiratory, Vaccine) of different phase mainly Phase (24], Phase II (6) and others. • Involved in managing end-to-end Clinical Projects from RFP to Project Close Out. • Managing the clinical trials budgets, vendors, coordinating with various departments (DM, BIOS, MM, MW, PV, CSM, IVRS, Labs) to ensure that study delivery as timelines and high quality data. • Experienced US-FDA on-site Inspections (2) and other RAs (CDSCO, KFDA), various sponsors and in-house audits. Education: • Post graduation in pharmacy (Pharmacology) from Manipal University (formally called Manipal Academy of Higher Education), and MBA (part-time) in FinanceSpecialties: • Managing complex clinical research project and leading teams in executing the project.• Developing/ reviewing clinical research documents, managing and training clinical team members.• Develop clinical trials Budget and ensuring that project deliverables are meeting the study timelines in the allocated budget.