Mary Arnould is Director, Center of Excellence & RBM Lead at Astellas Pharma and has been at Astellas over 3 years. She has over 25 years of clinical operations and site monitoring management experience, focusing on RBM implementation since 2014. Mary is currently leading RBM implementation and the Clinical Compliance Team at Astellas. Her vast clinical operations and monitoring experience has allowed her to help evolve the risk-based approach implemented at Astellas exploring ways to evaluate effectiveness, promote adaptability, leverage technology, and enhance processes to meet the challenges presented by the current pandemic. Mary is an active member in the TransCelerate RBM work stream.

Esther is an Associate Director in the Monitoring Excellence Group at Bristol-Myers Squibb, where she has spent the past several years developing and operationalizing the Risk-Based Monitoring methodology. In her current role, Esther facilitates the changes in technology, process, and monitoring support to embed RBM at BMS. Esther has 20 years’ experience in clinical trials, with a focus in site monitoring and the evolving Site Monitor role.