• Lead the management and oversight of contract Clinical Research Associates; utilize MindMed or CRO systems (when outsourced) to review Monitoring Visit Reports, monitoring visit scheduling, monitoring metrics, protocol deviations, issues, and action items to ensure data quality • Serve as Sponsor contact for external service providers/vendors with overall responsibility ensuring deliverables are executed with high quality and within timelines and budget • Oversees and tracks CRO/Vendor partners to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed • Maintain therapeutic knowledge and familiarity with clinical protocol(s) and project(s) as appropriate • Work with CRO/Vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met • Oversight of CRO monitoring team activities and deliverables • Assist QA with site audits • Review and contribute to study protocols, changes in eCRF design, laboratory manuals, monitoring guidelines, pharmacy manuals, informed consent forms, and other study-related documents/plans • Perform financial management, including review and approval of site contracts and budgets, as well as CRO/Vendor invoices and accruals with oversight by the Senior Director of Clinical Operations • Assist in tracking and coordination of trial related materials, including investigational product, clinical trial and laboratory samples, etc. • Organize and manage site round-table meetings and site recruitment meetings • Participate in the development, review and implementation of departmental SOPs, systems (CTMS and eTMF) and processes • Provide oversight and act in an SME capacity for Medidata CTMS • Provides oversight of external service providers used for the trial for both in-house and outsourced studies; responsible to ensure selection, and set up, including scope of work (SOW) and specifications are in line with protocol requirements, budget, and timelines • Ensures that the trial team operates in a constant state of inspection-readiness. Collaborate with Quality liaisons to ensure quality oversight of assigned trial utilizing the available tools • Ensures trial team members have received the appropriate trial-specific training needed for their function; in collaboration with the study clinician, ensures appropriate trial-specific training is given to trial team members and/or to the CRO.