Urvashi Patel
About Urvashi Patel
Urvashi Patel is the Sr. Manager of Clinical Trial Disclosure at Bristol-Myers Squibb, with extensive experience in clinical trial management and regulatory compliance.
Current Role at Bristol-Myers Squibb
Urvashi Patel currently serves as Sr. Manager Clinical Trial Disclosure at Bristol-Myers Squibb in Summit, New Jersey, United States. In her role, she manages the redaction of clinical documents in adherence to global regulations such as EMA Policy 0070 and Health Canada Public Release of Clinical Information (PRCI). She also oversees vendor support for data sharing, redactions, and the preparation of lay summaries. Patel is also responsible for tracking and reporting plain language summary and redaction metrics.
Previous Employment at Celgene
From 2014 to 2019, Urvashi Patel worked at Celgene as Manager Clinical Trial Disclosure and Data Sharing. During her tenure, she developed training programs and led change management initiatives related to Plain Language Summaries and the EU Clinical Trial Regulation. She coordinated with internal and external stakeholders to improve processes and address unmet needs, contributing significantly to the company's compliance and operational efficiency in clinical trial disclosures.
Roles at PRA Health Sciences and Merck/Schering Plough
Urvashi Patel's career includes notable roles at PRA Health Sciences and Merck/Schering Plough. She worked as Sr. Clinical Trial Specialist at PRA Health Sciences from 2012 to 2014. Prior to that, she held positions at Merck/Schering Plough from 2005 to 2012, starting as a Trial Specialist before being promoted to Sr. Trial Specialist. In these roles, she gained extensive experience in clinical trial management and contributed to multiple successful projects.
Early Career and Education
Urvashi Patel began her career as a Clinical Research Associate at International Technidyne Corporation from 2003 to 2005 and as a Research Associate at DGI Biotechnologies, Inc. from 2000 to 2003. She holds a degree from Kean University, which laid the foundation for her extensive career in the clinical research and pharmaceutical industries.
Industry Contributions and Expertise
Throughout her career, Urvashi Patel has been involved in developing job aids, work instructions, and user guides to train new staff. She has supported FDA and internal audits, and maintained a working knowledge of the evolving global regulatory environment. Her expertise in monitoring disclosure requirements ensures that the clinical trials adhere to stringent guidelines, providing data transparency and compliance.