• Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study • Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements • Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies • Create annotated visit report templates and other documents and strategies related to site management and monitoring • Support training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented • Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements • Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control • Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team • Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed