Lydia Matombo
Director, Risk Evaluation & Adaptive Integrated Monitoring
Merck & Co., Inc.
Lydia Matombo is a Director, Risk Evaluation & Adaptive Integrated Monitoring (REAIM). In her role, she establishes technical and cross functional business needs, aligns with stakeholders, and oversees data integration activities between Merck and Suppliers resulting in the build out, testing, implementation and maintenance of Risk Analysis deliverables such as Key Risk Indicators (KRI)s or Quality Tolerance Limits (QTLs) in support of Adaptive Integrated Monitoring (AIM), Global Clinical Trial Operation’s (GCTO) risk based initiative to further the organization’s risk-based quality management (RBQM) approach through advanced analytics.
She ensures that supplier systems are ready and maintained throughout the study life cycle to enable execution of central analytics and monitoring activities, including Quality Tolerance Limit analysis, Key Risk Indicator analysis and Central Statistical Analytics. This enables each Clinical Trial Team to support the effective identification of important study issues that require monitoring, management, and adaptation of study plans.
Ms Matombo collaborates with other functions, Quality Assurance, Ethics and compliance, to ensure that systems and any outlined processes are compliant and Inspection ready.
Ms Matombo has more than 20 Years of clinical database management expertise, leading end to end clinical trial conduct and execution, strategic implementation of quality-by-design data collection systems, building and leading high-performing teams across many therapeutic areas, and is now in the role of Risk Systems Data Integration Lead.
Ms Matombo is committed to creating a diverse and inclusive work environment. She is a member of the GCTO’s Diversity, Equality and Inclusion Ambassadors as well as Merck’s League of Employees of African Descent (LEAD).
Ms Matombo holds a BSN (Honors) from Fairleigh Dickinson University in New Jersey, is a Registered Nurse, and is Project Management Professional (PMP®) certified.