Shawn Grady
About Shawn Grady
Shawn Grady is an E Trial Master File Senior Analyst at Bristol Myers Squibb in Lawrenceville, NJ, with extensive experience in clinical research and regulatory analysis.
Current Role at Bristol Myers Squibb
Shawn Grady currently serves as an eTrial Master File Senior Analyst at Bristol Myers Squibb, based in Lawrenceville, NJ. In this role, he provides technical expertise in the Electronic Trial Master File (eTMF) and supports clinical trials throughout their lifecycle. His responsibilities include monitoring adherence to ICH/GCP Guidelines, regulatory requirements, ALCOA+ Principles, and internal client policies to ensure completeness and accuracy at the document level. Additionally, he generates, organizes, and delivers performance metrics for various functional areas within eTMF Operations.
Previous Experience at Merck & Co./Icon Clinical Research
From 2009 to 2021, Shawn Grady worked at Merck & Co./Icon Clinical Research as an Essential Document Specialist - Team Lead in North Wales, PA. Over his 12-year tenure, he was responsible for leading a team and ensuring that essential documents were managed with precision and in accordance with industry standards.
Consultant Roles at Wyeth and GlaxoSmithKline
Shawn's experience includes positions as a Jr. Regulatory Analyst at Wyeth (now Pfizer) through Devon Consulting for 4 months in 2008-2009 in Collegeville, PA, and as a Clinical Study Associate at GlaxoSmithKline through ClinForce, LLC (now DOCS Global) from 2006 to 2008 in King of Prussia, PA. His role at Wyeth involved consulting on regulatory matters, while his position at GlaxoSmithKline involved coordinating clinical studies.
Early Career at Medifacts International
Shawn served as a Project Coordinator and Data Specialist at Medifacts International (now BioClinica) in Rockville, MD from 2005 to 2006. Initially working as a Data Specialist for 5 months, he then transitioned to a Project Coordinator role for a year. His responsibilities included managing project data and coordinating various aspects of clinical trial projects.
Educational Background
Shawn Grady holds a Bachelor’s Degree in Environmental Management from the University of Maryland University College, where he studied from 2010 to 2015. Additionally, he completed studies in Economics and Small Business, earning a Business Management qualification from Delaware County Community College between 2007 and 2008.