Denise joined Halloran Consulting Group in 2011. She oversees the quality auditing business and also focuses on quality risk management techniques for clinical studies, including risk-based monitoring and vendor management. She has led multiple clinical development gap analyses and process development projects, including a number of quality system redesign initiatives.
Denise has over 15 years of experience in clinical development, providing consulting services to a wide range of pharmaceutical, medical device, biotech, and CRO clients in the US and Europe. Denise has worked with numerous companies to implement Electronic Data Capture (EDC), including process development, role development, and training, with a special emphasis on adapting monitoring practices to take advantage of EDC technology.
Prior to joining Halloran, Denise was Director of Clinical Planning and Performance at Vertex Pharmaceuticals, where her group coordinated planning activities, process development, and performance metrics among the clinical study team functions. She held project management positions at Searle (clinical project management) and Enmed (EDC). Prior to her work in clinical development, Denise was a teacher of English language and literature at the secondary and university levels, including three years in Tunisia as a member of the United States Peace Corps.
Denise holds a Master of Science from the University of Pennsylvania, a Master of Arts from Villanova University, and a Bachelor of Arts from Dickinson College.