ashok aditya vambarilli

• As a domain expert to take part in Techno-commercials and Strategy development meetings to develop Pharma-IT solutions to the customers in the areas ranging from Drug Discovery-Clinical research-Regulatory Filing. • Respond to client RFPs by developing Proof of concept around use cases. • Collaborate with growth office and sales team in devising point specific and solution offerings to the clients. • Worked as Business analyst on Veeva Clinical services (Veeva vault) for Pharmaceutical client.

• As a PM/Scientist to handle end-to-end Clinical Programs (PK studies in Patients, Food effect studies, Bioavailability/ Bioequivalence studies, Phase-I & III Clinical Trials) • Carry out Study feasibility-technical evaluation, Budget assessment, bid defense, site/CRO identification & selection, Study start up (Site Initiation Visit), Investigator meetings, Study maintenance, Clinical Supplies Management, Identification of study level risks, Monitoring (Sponsor oversight),CRA meetings, Study close out

• As a Project Manager and PK scientist to handle PK, BA-BE studies in Patients/NHV & Phase III studies of Indian Submissions. • Prepare RFP, protocol synopsis in liaison with Project Leads/Medical Leads. • Oversight on IB, Protocols, ICF, CRF, Patient Diaries & Other Study Manuals (IMP Management Manuals, Project management manuals, Central Lab-Bio sample management manuals, Study Oversight manuals, EDC manuals, Clinical Data management manuals etc. as applicable) • Oversight on CRO & Sites qualification

• As a Project Manager in a client facing role, work with Indian & global clients for their Clinical trials Sites management and other regulatory services such as GCP, GLP, GXP, GMP services. • Handling SMO projects of Clinical Trials of Phase I-III & BA-BE, PK studies at Various sites across India for different therapeutic indications like Oncology, Dermatology, Endocrinology, Obesity and respiratory. • Direct, lead, monitor and manage the Project Teams and work with diverse stakeholders at site.

• Analysis of plasma/serum/blood/urine bio-samples as per GLP using LC-MS/MS in compliance to regulatory guidelines such as USFDA, EMA, ICH M10 etc. • Bio analytical Method development & Method validation using LC-MS/MS - API 4000 (ABS Sciex). • Facing Bio-analytical Audits/sponsor audits at GLP lab. • Review & preparation of BA reports as per regulatory requirements