Katherine (Kathy) Taylor is Head of Risk Evaluation & Adaptive Integrated Monitoring (REAIM). In her role she leads the implementation, delivery, and all aspects of Adaptive Integrated Monitoring (AIM), Global Clinical Trial Operation’s (GCTO) continuous improvement initiative to further the organization’s risk-based quality management (RBQM) through advanced analytics.
As the head of REAIM, Kathy champions cross-functional engagement and alignment on the AIM strategy and execution of AIM activities in clinical trials. This includes development of central monitoring plans (CMPs) and clinical data specifications aligned with critical data, process, and risk assessments. She ensures execution of central analytics and monitoring activities, including Quality Tolerance
Limit analysis, Key Risk Indicator analysis and Central Statistical Analytics to support identification of important study issues that require monitoring, management, and adaptation of study plans.
Kathy has 25 years of experience managing the quality of clinical trial conduct and execution, strategic implementation of quality-by-design principles, building high-performing teams, database management expertise and leading all aspects of GCP health authority inspections. She is a sought-out industry speaker for optimizing inspection readiness and the exacting risk-based quality management methodologies.
Kathy is committed to creating a more diverse, equitable, and inclusive work environment. She is a member of the inaugural GCTO Diversity & Inclusion Council as well as Merck’s League of Employees of African Descent (LEAD), serving on the Group Mentoring Project Team.
Kathy holds a master’s degree in business administration (management) from Eastern University and a bachelor’s degree in natural science/biology from Indiana University of Pennsylvania.