Merck Reporting on Site Monitoring, Performance and Database Lock

Andrew Onikepe is the North America Regional Director, Monitoring Excellence, Global Clinical Trials Operations at Merck. In this role, Mr Onikepe supports global standardization of all aspects related to clinical site monitoring for studies managed internally by Merck, including: process, systems, CRA onboarding, monitoring technology, training and oversight.Mr Onikepe has over 15 years pharmaceutical industry experience in various country operations roles including some with global impact and he has led several country and global process initiatives, most recently leading implementation of Project RESTART. RESTART uses principles of risk-based quality management to help country operations and CRAs in particular focus their on-site monitoring activities on the areas of greatest importance and potential risk during the COVID-19 pandemic.Mr Onikepe holds a BS in Biology from the University of Pittsburgh and a MS in Project Management from Colorado Technical University.

With over 20 years leading change at Merck, Merle Schneider has led many innovation projects primarily in the global clinical development area. She has experience using many methodologies and techniques including Lean, Six Sigma, Change Management, Business Process Management, Design Thinking and most recently Agile Product Development as the business lead for SMART, Merck’s industry leading, internally developed mobile application for site monitoring. Prior to her role leading the development of SMART, she was the Global Process Steward for Merck Research Labs Global Clinical Development organization where she transformed the company’s document based SOP system to business process management software-based model improving users ability to find information and standardizing and simplifying across multiple process spaces.She has been change lead for many large-scale initiatives including the merger of Merck and Schering Plough’s Global Clinical Trial Operations group, simplification of the programmatic outsourcing model and implementing a new operational model in basic research for process and scientific capability management, to name a few. Merle is passionate about innovation, quality improvement, process simplification and helping people implement better and more efficient ways of working.

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, Ms Taylor 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.Ms Taylor 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.Ms Taylor is committed to creating a more diverse 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