Pinkey Tupparwar
About Pinkey Tupparwar
Pinkey Tupparwar is the Director/Global Process Lead TMF at Bristol-Myers Squibb, with extensive experience in clinical trial management and regulatory compliance.
Current Role at Bristol-Myers Squibb
Pinkey Tupparwar currently serves as the Director and Global Process Lead for TMF (Trial Master File) within Global Development Operations at Bristol-Myers Squibb. Based in the Greater New York City Area, Tupparwar is responsible for overseeing the electronic management of clinical trial documents, ensuring compliance with regulatory standards, and leading the development and implementation of global processes.
Past Experience at Shionogi Inc.
Before her current role, Pinkey Tupparwar was a Manager for TMF in Global Clinical Development at Shionogi Inc. from 2017 to 2019. In this position, she was involved in managing clinical trial documentation, ensuring the organization adhered to regulatory requirements, and improving overall document management processes within the company.
Background in Clinical Research and Operations
Tupparwar has a significant background in clinical research and operations, having worked as a Sr. Clinical Trial Specialist at Johnson & Johnson (Integrated Resources) from 2015 to 2016, and as a Clinical Operations Management Specialist at Celgene (Aerotek) from 2013 to 2015. Her roles have consistently involved the oversight and management of clinical trial documents, ensuring compliance, and enhancing operational efficiency.
Educational Background in Healthcare Management and Biomedical Engineering
Pinkey Tupparwar holds an MBA in Healthcare Management from Goldey-Beacom College, completed between 2012 and 2014. Additionally, she has a Master's degree in Biomedical/Biotech Engineering from the University of Massachusetts Lowell, achieved from 2007 to 2010. Her education has provided her with a strong foundation in both the technical and managerial aspects of clinical trial management.
Expertise in eTMF Management and Regulatory Compliance
Tupparwar is highly skilled in eTMF Management, FDA Inspections & Audits, and Clinical Research Ethics. She has extensive experience ensuring that clinical trial systems and processes meet regulatory standards, and she specializes in maintaining quality control and compliance within her field. Additionally, her expertise encompasses validation processes critical to the integrity and success of clinical trial management.