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How To Adjust Monitoring Plans To Accommodate Decentralized Trials
Thursday, February 10th | 1:10 - 1:40pm
Nicole Stansbury, Vice President, Clinical Monitoring & Central Monitoring Services
Nicole Stansbury, Vice President, Clinical Trial Management, joined Syneos Health in February 2019 and is responsible for global clinical trial management and monitoring strategy. Prior to leading the global CTMs at Syneos, Nicole led the Global Central Monitoring team and risk -based monitoring strategy, process and tools.
Nicole has 30 years of experience in the industry beginning as a study coordinator in a multi-therapeutic site followed by 21 years at a large, global CRO where she spent several years as a Clinical Research Associate (CRA) and Project Manager (PM) before moving into leadership roles. Nicole’s leadership roles included Head of Clinical Management in the Central US where she oversaw Clinical Team Managers (CTMs), CRAs and administrative staff and Head of Global Clinical Performance, a group responsible for clinical metrics, systems, process and quality where Nicole led the development of the risk-based monitoring (RBM) strategy, process and tools. Nicole has consulted with biotech companies on ICH E6 R2 compliance, conducted risk management training, performed a detailed assessment of EDC, CTMS, RBM and eTMF technologies for a small CRO and completed a risk management and centralized monitoring process assessment for a large pharmaceutical company.