o Direct and manage CRO interactions, including sponsor oversight of all clinical operations activities (e.g., study management, monitoring, site management, trial master files, etc.)
o Work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
o Oversee CRO activity including but not limited to the clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
o Direct and manage all clinical operations activities for assigned clinical trial(s)
o Direct and manage the study project plan, including timeline, budget, and resources o Participate in protocol, CRF and strategy development, Clinical Study Report preparation, NDA submission, as appropriate