Nareshkumar Narayanwal

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.

Experience

1. Associate Director, Global Trial Acceleration Center

   Bristol-Myers Squibb India Pvt. Ltd

   Feb 2025 — Present · Hyderabad, IN

Education

• Manipal Academy of Higher Education

  Master of Pharmacy, Pharmacology

  2001 — 2003

Skills

• Clinical Trials
• Clinical Monitoring
• Ich-Gcp