Dr. Alpesh Rajput Email and Phone Number

Profile SummaryQualified clinical research physician with a progressive experience of more than 18 years. Medical graduate (MBBS) from B. J. Medical College, Ahmedabad, Gujarat. A highly motivated professional with a work experience in leading CROs and clinical operations of Phase-I, PK-PD, Bioavailability/Bioequivalence studies. Facilitated study conduct and provided study management support to local teams / CRAs in India. Lead in development of Clinical Study Reports, Protocols, Case Report Forms, Consent Forms, and Case Narratives. Supported submissions to USFDA, Health Canada and UK-MHRA, ANVISA, etc.Clinical Operations Experience• Lead Clinical Research Centre for conduct of Various studies.• Conducted approximately 500+ studies as “An Investigator”. • Expertise in preparation of new SOPs, trials related documents (Protocols, CRF, eCRF, Data analysis plan, reports etc.) medical writing and their effective implementations. • Have knowledge and thorough understanding of ICH-GCP guidelines, Indian GCP guidelines, Schedule Y of Indian drugs and Cosmetic act and other various regulatory guidelines for the conduct of clinical studies like USFDA, MHRA, ANVISA, WHO, CANADIAN, TGA etc.Successfully lead and participated in different audits e.g. USFDA, AFSSDPS/DKMA, ASPEN, ANVISA, EMEA, DCGI, MALASIYA, GLP, AGES, ISO 14000 AND 18000, OSHAS,>100 Sponsor audits exposure• Demonstrated ability to work effectively in a team environment, manage multiple priorities, exercise sound judgment, take initiative, be flexible, work well under pressure and positive attitude. • Robust Managerial/Senior level experience in running clinical operational teams and management of clinical trials.Key role in CRO selection for study outsourcing process.Done clinical monitoring of >100 studies in different CROs across India.