About this role
Responsible for project activities associated with monitoring functions of Phase I through Phase IV clinical research studies and Real World Evidence (RWE) studies, as an expert in the drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs oversight of all study-related site management and monitoring activities for the assigned studies in adherence to all applicable regulatory guidelines, study Key Performance Indicators (KPIs), Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Standard Operating Procedures (SOPs).