* Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results
* Leading risk assessment and identifies risk mitigation strategies at the study level
* Manage and oversee 3rd party vendors and global CROs
* Conducting site evaluation and selection
* Leading investigator meeting preparation and execution
* Monitoring progress for site activation and monitoring visits and acts on any deviations from plan
* Managing development and implementation of patient recruitment and patient retention strategies
* Monitoring data entry and query resolution and taking action on any divergence from agreed metrics
* Overseeing and providing input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation