David Lew

Background

I am an Adjunct Lecturer in the Master of Science in Regulatory and Clinical Research Management program at Regis College, where I teach graduate-level coursework in clinical research project management and FDA regulations.

I have more than twenty-two years of professional experience in global clinical research, including senior leadership roles at contract research organizations. My writing focuses on practical guidance for clinical development, clinical operations, regulatory affairs, and project management audiences.

Education, credentials, and service

I am pursuing a doctoral degree. My education includes degrees from Johns Hopkins University and the University of Washington, dual BS degrees in Biochemistry and Biology, and certifications including PMP, CCRA, and ACRP Project Manager.

I serve as a Board Member of the Organization of Regulatory and Clinical Associates. My Amazon author bio also notes a 2021 PharmaTimes Clinical Researcher of the Year Project Manager award.

Related work

I also build practical tools, including DocCite, a private, offline clinical research document search app with cited proof, and Eat Chess, a series of chess-inspired games for puzzle people.

Contact

For book, course, or professional inquiries, email [email protected].