Clinical Trial Manager

What You'll Do Review scope of project and resourcing related to Clinical Monitoring with Clinical Project Management Plan, schedule, and implement the clinical monitoring aspects of projects Define and implement project-specific functional standards, goals, and expectations with Clinical Monitoring team including KPIs, KRIs, QTLs and additional metrics as agreed upon Primary point of contact for Clinical Monitoring aspects of designated projects Serve as advocate for the Clinical Monitoring team with the client Coordinate and oversee daily operations of Clinical Monitoring team, including CRAs and in-house personnel. Ensure assigned CRAs receive therapeutic and project-specific training Develop CRA tools and CRA training materials Organize and conduct CRA meetings/calls if in project scope Ensure accurate tracking of any relevant study information related to Clinical Monitoring deliverables Oversight of key clinical monitoring metrics, including but not limited to: Visits scheduled per CTMP, Monitoring Visit Reports (MVR) and associated correspondence timelines, Action Items (AI), query resolution, and other quality metrics, to ensure they are met and followed-up on as necessary Provide oversight of visit report review and approval, including site issue escalation and resolution; may conduct visit report review and approval depending on team structure Manage clinical monitoring related project milestones and proactively address deficiencies Oversee the quality and timeliness