• Provide expertise, strong leadership, and management. • Ensure that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable Standard Operating Procedures (SOPs), regulations, Good Clinical Practice, and study-specific requirements. • Review visit reports and manage any issues brought to their attention by CRA staff and/or the study team and/or Sponsor. • Oversee Corrective Actions/ Preventive Actions (CAPAs) of assigned staff to ensure timely and sufficient resolution. • Track clinical monitoring metrics such as number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required training. • May conduct monitoring visits to offer support to project teams. • Participate in the preparation, conduct and resolution of audits and inspections. • Contribute to the development, revision, and implementation of Clinical Monitoring SOPs, processes, and study tools. • Serve as a management contact for sites, project teams, and sponsors when issues related to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved. • Identify and implement professional development and performance evaluations. • Act as a mentor to team members to ensure growth and career development. • Ensure projects/studies are resourced appropriately by allocating and/or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of assigned staff. • Conduct Monitoring Oversight Visits to ensure compliance of clinical monitoring team members with regulations, SOP’s, and study requirements. • Prepare and review budgets for RFPs, as assigned. • Participate in Bid Defense Meetings, as assigned. • Perform ongoing reconciliation of clinical monitoring activities against budget. • Perform additional duties assigned by Clinical Monitoring leadership.