ashok aditya vambarilli
Angestellt, Team Lead - Healthcare & Life sciences - Clinical research Domain consultant, Tech Mahindra
Bangalore, State of Karnataka, India, Indien
Über mich
A Clinical Research professional with overall 11 years of experience in # IT-Health care & Life science, Project Management (Clinical & Non Clinical research), Clinical Pharmacokinetics(PK), Clinical operations (GCP), Bio-Analytical (GLP), Medical Writing, Quality management Systems, Vendor/CRO Qualification & Budget management. I worked with different companies including, Global IT (Tech Mahindra) and Pharma Companies (Biocon Pharma ltd, Biocon Biologics, Dr. Reddys Laboratories) and CROs (Axis Clinical Pvt Ltd, Pharmazone) in India. Worked 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) of ANDA (Generics), NDA & BLA submissions. Looking for Jobs in Clinical Research of Generic drug development/ New drug discovery
Werdegang
Berufserfahrung von ashok aditya vambarilli
Bis heute 2 Jahre und 1 Monat, seit Mai 2022
Team Lead - Healthcare & Life sciences - Clinical research Domain consultant
Tech Mahindra
• 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.
4 Jahre und 1 Monat, Mai 2018 - Mai 2022
Associate Scientific manager I - Medical affairs & Clinical Research
Biocon Pharam Ltd
• 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
1 Jahr und 8 Monate, Okt. 2016 - Mai 2018
Scientist Clinical Pharmacokinetics Global Clinical Management
Dr Reddys Laboratories Ltd
• 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
4 Jahre, Okt. 2012 - Sep. 2016
Project Manager Clinical Research
Pharmazone
• 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.
11 Monate, Apr. 2011 - Feb. 2012
Research Associate I Bioanalytical Department
Axis Clinicals Ltd
• 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
Sprachen
Englisch
Fließend