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David Lew

Goodreads Author

Born

The United States

Genre

Nonfiction

Member Since

February 2026

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David Lew is an Adjunct Lecturer in the Master of Science in Regulatory and Clinical Research Management program at Regis College, where he teaches graduate-level coursework in clinical research project management and FDA regulations. His academic instruction is informed by more than twenty-two years of professional experience in global clinical research, including senior leadership roles at contract research organizations.

David’s professional background spans project and program management, clinical operations, and organizational leadership, with direct involvement in Phase I, Phase II, and Phase III clinical trials across oncology and other therapeutic areas.

In addition to his academic appointment, David remains actively engaged in cont ...more

Combine Editions
David Lew’s books

Average rating: 5.0 · 6 ratings · 1 review · 4 distinct works

	FDA Regulatory Affairs: Operational Guidance for Clinical Development it was amazing 5.00 avg rating — 4 ratings — 5 editions	Error rating book. Refresh and try again. Rate this book Clear rating 1 of 5 stars 2 of 5 stars 3 of 5 stars 4 of 5 stars 5 of 5 stars
	Clinical Research Project Management: Operational Leadership for Clinical Trials it was amazing 5.00 avg rating — 1 rating — 5 editions	Error rating book. Refresh and try again. Rate this book Clear rating 1 of 5 stars 2 of 5 stars 3 of 5 stars 4 of 5 stars 5 of 5 stars
	Clinical Trial Financial Management: A Clinical Research Field Guide it was amazing 5.00 avg rating — 1 rating — 3 editions	Error rating book. Refresh and try again. Rate this book Clear rating 1 of 5 stars 2 of 5 stars 3 of 5 stars 4 of 5 stars 5 of 5 stars
	Clinical Operations: A Comprehensive Clinical Research Field Guide 0.00 avg rating — 0 ratings — 3 editions	Error rating book. Refresh and try again. Rate this book Clear rating 1 of 5 stars 2 of 5 stars 3 of 5 stars 4 of 5 stars 5 of 5 stars

* Note: these are all the books on Goodreads for this author. To add more, click here.

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David’s Recent Updates

David Lew made a comment in the group Goodreads Librarians Group — Please combine current editions for two David Lew books topic " Hello, The Goodreads combine tool reported that these jobs were enqueued, but the editions are still listed as separate works. Please combine each set ...more "
Jul 26, 2026 08:01PM
David Lew made a comment in the group Goodreads Librarians Group — This book is not mine, please move it (part 20) topic " These books are not mine (and written by a different "David Lew"). https://www.goodreads.com/book/show/1... https://www.goodreads.com/book/show/2... htt ...more "
Feb 23, 2026 11:50AM
David Lew joined the group Goodreads Librarians Group
Feb 23, 2026 11:45AM · like
David Lew rated a book it was amazing FDA Regulatory Affairs: Operational Guidance for Clinical Development (Clinical Research & Regulatory Affairs) by David Lew (Goodreads Author)	Error rating book. Refresh and try again. Rate this book Clear rating 1 of 5 stars 2 of 5 stars 3 of 5 stars 4 of 5 stars 5 of 5 stars
Feb 23, 2026 08:22AM · like
David Lew rated a book it was amazing Clinical Research Project Management: Operational Leadership for Clinical Trials (Clinical Research & Regulatory Affairs) by David Lew (Goodreads Author)	Error rating book. Refresh and try again. Rate this book Clear rating 1 of 5 stars 2 of 5 stars 3 of 5 stars 4 of 5 stars 5 of 5 stars
Feb 23, 2026 08:17AM · like
David Lew rated a book it was amazing FDA Regulatory Affairs: Operational Guidance for Clinical Development (Clinical Research & Regulatory Affairs) by David Lew (Goodreads Author)	Error rating book. Refresh and try again. Rate this book Clear rating 1 of 5 stars 2 of 5 stars 3 of 5 stars 4 of 5 stars 5 of 5 stars
Feb 23, 2026 08:13AM · like
David Lew rated a book it was amazing FDA Regulatory Affairs: Operational Guidance for Clinical Development (Clinical Research & Regulatory Affairs) by David Lew (Goodreads Author)	Error rating book. Refresh and try again. Rate this book Clear rating 1 of 5 stars 2 of 5 stars 3 of 5 stars 4 of 5 stars 5 of 5 stars
Feb 23, 2026 08:12AM · like
David Lew rated a book it was amazing Clinical Research Project Management: Operational Leadership for Clinical Trials (Clinical Research & Regulatory Affairs) by David Lew (Goodreads Author)	Error rating book. Refresh and try again. Rate this book Clear rating 1 of 5 stars 2 of 5 stars 3 of 5 stars 4 of 5 stars 5 of 5 stars
Feb 23, 2026 08:11AM · like