Nicole Stansbury Vice President, Central Monitoring Services
Syneos Health
Nicole Stansbury, Vice President, Central Monitoring Services, joined Syneos Health in February 2019. Nicole has 29 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 assessments 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.
Nicole has a yellow belt in Lean Six Sigma, completed a Global Leadership program, received the 2011 CEO Leadership Excellence Award, met with the FDA in 2014 to share RBM strategy ideas, participated on ACRO’s RBM Forum, presented at numerous industry conferences on RBM and published several articles on RBM and Change Management.
Nicole has a B.S. in Animal Science from Texas A&M University.