Position Purpose:The Senior Study Manager (SSM) has responsibility for one or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studiesThe SSM leads and manages the tactical execution of one or more clinical studies from study startup through database release and inspection readiness to ensure timely delivery of quality study data.The SSM provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study executionThe SSM may also input to and support compilation of sections to Clinical Study Reports 

Leads and oversees all elements of study start-up and monitoring functions both internally and at the CROs to ensure delivery and compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards

MS/PhD minimum of 3 years relevant experienceExtensive global clinical trial/study management experience