Operational Study Management for 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies
- Accountable for the development of realistic detailed study startup and monitoring plans
- Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs , approving sites, and assessing site activation plans
- Leads study risk planning process in context of site and subject
- Coordinates study/protocol training & investigator meetings
- Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
- Accountable for the delivery of the study against approved plans