The roles and professional competencies of clinical study coordinators and data managers in clinical trials: A systematic review

Daniele Napolitano, Simone Amato, Elisabetta Creta, Francesca Profeta, Elisa Foscarini, Eleonora Ribaudi, Alessia Leonetti, Caterina Fanali, Gianluca Ianiro, Antonio Gasbarrini, Vincenzina Mora, Fanali Caterina, Leonetti Alessia, Wlderk Giulia, Graziani Cristina, Capodrossi Anna, Teberino Maria Anna, Savini Roberta, Alberelli Maria Adele, Palmarino Francesca, Leonti Gabriela, Murdolo Marina, Vetrone Maria Amelia, Zavarella Maria Antonietta, Creta Elisabetta, Foscarini Elisa, Profeta Francesca, Turchini Laura, Amatucci Valeria, Schiavoni Elisa, Durini Eleonora, Giordano Luciana

Clinical Trials: Journal of the Society for Clinical Trials

Published online on November 21, 2025

Abstract

Clinical Trials, Volume 23, Issue 2, Page 189-197, April 2026.
Background:The increasing methodological and regulatory demands of clinical trials have increased the need for clearly defined roles, particularly for Clinical Study Coordinators (CSCs) and Data Managers (DMs). While these professionals play crucial roles ...