Working Group Scope |
Although Risk Based Monitoring is no longer considered a new way of working, it continues to stay an area that is constantly evolving. Changes in landscape due to the pandemic are accelerating this evolution. This Working Group will identify innovative approaches in risk management and data analytics to proactively manage data quality and subject safety risks. The Working Group will support the pharmaceutical industry with change management challenges related to moving towards risk-based approaches. |
Marion Wolfs: Working Group Lead
Marion Wolfs is Head, Risk Management-Central Monitoring (RM-CM) within the Integrated Data Analytics and Reporting (IDAR) organisation from Janssen Pharmaceutical Companies of JnJ. In this role Marion provides leadership and strategic direction for all activities in the RM-CM department and oversees enterprise wide implementation of ARBM at JnJ. Marion joined the pharmaceutical industry in 2007 and worked in various clinical operations roles until joining the Risk Management-Central Monitoring Group in October 2014. She was the RBM TransCelerate Co-Lead from 2016 till 2019. She holds a Master of Science degree in Biomedical Sciences from the Maastricht University and an International Certificate in Enterprise Risk Management from IRM in London. | Michael Walega: Working Group Lead
Michael Walega is the Head of Centralized Monitoring at BMS. He is responsible for providing protocol teams with actionable insights to achieve higher quality, ensuring centralised monitoring processes are aligned to relevant regulatory requirements, and championing risk-based quality management approaches to clinical trial monitoring activities. He was previously at LabCorp/Covance, where he led the team responsible for development and growth of Covance’s Risk-Based Monitoring (RBM) solutions, processes and operational delivery. He also led the Late-Stage Biostatistics and Programming groups, as well as the Process Excellence team. Michael is a qualified biostatistician and a Six Sigma Master Black Belt. |
