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 recently appointed as Head, GCTO enterprise Shared Services Center (eSSC ) and will champion Merck's work in fostering a diverse, highly skilled clinical trial operations talent pool.  The eSSC recently celebrated its two-year anniversary, a key milestone of progress in our mission to deliver high-quality clinical trial support services with a skills-first, agile hiring approach.  Building upon the successful foundation, the eSSC will now expand services to the full GCTO organization. The eSSC is one of the major contributors to OneTen candidates enterprise wide. They play a significant role in helping us shape and cultivate the workforce of the future.Katherine brings more than 28 years of experience managing the quality of clinical trial conduct and execution. Since 2021, she has served as the Head of the Risk Evaluation & Adaptive Integrated Monitoring (REAIM) organization. In this role, Katherine led the implementation, delivery, and all aspects of Adaptive Integrated Monitoring (AIM). Prior to that, she was Director, Clinical Quality Operations (CQO) Lead, in the oncology therapeutic area, proactively embedding quality into our clinical trials. Katherine joined our company in 2016 as Associate Director, GCP Inspection Lead, within Quality & Continuous Improvement (QCI).Katherine is deeply committed to creating a more diverse, equitable and inclusive work environment. She is a member of the inaugural GCTO Diversity, Equity & Inclusion Council and has been a member of the League of Employees of African Descent (LEAD) since 2017, having served as Pennsylvania Chapter Career Chair and on the Mentoring Project Team. Kathy holds a master’s degree in business administration from Eastern University and a bachelor’s degree in natural science/biology from Indiana University of Pennsylvania.