Overview

“As a long-standing leader in the Society for Clinical Data Management (SCDM), Michael has a unique perspective on the evolving needs of our field. This book will serve as a much-needed, practical guide for ensuring high-quality, on-time clinical data deliverables—an essential part of bringing new treatments to patients around the world.” - Jonathan Andrus, Co-CEO, CRIO & Treasurer, SCDM Clinical Research is a fascinating industry, because 99.9% of human beings interact with it throughout their lives. However, very few understand the effort to bring a new medical product to patients in need, and an even smaller number have thought about, or remotely understand, the pivotal role Clinical Data Management (CDM) professionals play in this endeavor. Ranging from sharing hands-on experiences to providing concrete examples of how to propel one’s CDM career, Mastering Clinical Data Management: The Background, Experience, and Soft Skills Needed to Succeed in CDM is a glimpse of the author’s three decades long experience in the field. Decentralized Clinical Trial (DCTs), Risc Based Quality Management (RBQM), examining the trustworthiness of the data used in clinical research, or illustrating the use of Artificial Intelligence (AI) in CDM are just a few examples of topics this book, not only covers, but explains for all competency levels through real life examples. Despite Clinical Research in general, and the profession of CDM in particular, being a heavily regulated and tech-driven environment, this book uses every opportunity to emphasize the importance of the human in the loop. Therefore, in addition to gaining more insights into the fascinating world of CDM, this book provides the perfect “How to” of advancing one’s career and learning the art of CDM. The goal is to provide valuable insights for all levels of CDM professionals and those individuals that might consider a career in CDM. Key Features: - A view into clinical data and its importance as never seen before - Based on 35 years of hands-on CDM experience - Provides guidance and many examples of crucial soft skills needed to succeed in CDM - Provides arguments for all CDMs to excel in their current work environment - Reflects on the current regulatory framework and how it can benefit CDM

Full Product Details

9781041090724

Table of Contents

Reviews

""I have known Michael for over two decades, and throughout that time I have admired his vision, expertise, and dedication to advancing our profession. When he shared his idea for a book on best practices in clinical data management, I immediately saw the value it could bring to the industry and was honored to be invited to contribute as a reviewer. As a long-standing leader in the Society for Clinical Data Management (SCDM), Michael has a unique perspective on the evolving needs of our field. This book will serve as a much-needed, practical guide for ensuring high-quality, on-time clinical data deliverables—an essential part of bringing new treatments to patients around the world. I wish him great success in bringing this important work to publication."" -Jonathan Andrus, Co-CEO, CRIO & Treasurer, SCDM ""I had the pleasure of reporting to Micheal when we both worked at PRA / ICON. We built a strong relationship during that tenure and continue to stay in touch to exchange new perspectives in our industry. I was very excited when Michael mentioned to me earlier about his idea to put together a book on best practices in clinical data management. The industry is lacking a concise guide at this stage, and this reference book will fill a much needed gap in clinical data management. I felt honored when Michael invited me to write a chapter for the book. As one of the leaders in the Society for Clinical Data Management (SCDM), the clinical data management industry's recognized forum for nurturing best practices, Michael has an unique lens into the needs of the industry. I am confident that the book he is striving to get published will assist personnel in the industry in practicing end to end data management steps that will ensure on-time, high quality deliverables. Clinical Data Management deliverables will be a key factor in bringing much needed cures to patients worldwide."" -Zia Haque, Head of Data Management at Otsuka-US Pharmaceuticals ""As Chief Dat strategist and solutions officer I see too many companies not fully understanding the importance and value in their data. This starts with having a better understanding of best practises in data management, and where clinical data science is taking us as an industry. With publications like this book, written by experts such as Michael, which brings the data delivery and quality aspects to life through easy reading (including practical examples), the industry is one step closer to getting true value out of their data."" -Tanya du Plessis, Bioforum

Author Information

Michael Goedde is a Certified Clinical Data Manager with 35 years of experience in the pharmaceutical and biotechnology industry. His expertise ranges from hands-on clinical data management (CDM) activities to executive roles with responsibility for large international teams and strategic positioning for the companies he engages with. Michael has dedicated his professional career to the advancement of CDM as a recognized and respected profession in our industry, as well as providing mentoring for the next generation of CDM enthusiasts.

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