• The Case Review Manager leads the patient screening analysis and evaluation of baseline medical history and clinical imaging reports (e.g EDC screening records including clinic notes, lab results, cardiology assessments, CT and/or echocardiogram reports) to confirm protocol compliance and provide patient screening and case review support to clinical trial sites for Clinical Research Trials within THV Clinical Affairs • Serve as a subject matter expert (SME) to ensure trial patient safety by assuring compliance with clinical protocols through screening of medical history for early feasibility and pivotal trials in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with EW procedures and ethical standards • Lead the analysis and evaluation of baseline medical history including case report forms and source documentation (e.g medical records including clinic notes, right heart hemodynamics, medication lists, lab results, and pulmonary function tests) to confirm protocol compliance • Serve as subject matter expert by providing direction and guidance to execute deliverables in collaboration with study stakeholders and cross-functional teams • Provide medical insight and guidance to screening and trial management teams to expedite resolution of site requests • Conduct reviews and document medical narratives based upon screening/baseline source information to facilitate case reviews by study Screening Committees in accordance with regulatory requirements, trial safety processes, and EW procedures • Provide guidance and review medical history narratives from team members to ensure protocol compliance in accordance with screening process work instructions • Design training programs related to best practices for screening potential trial participants according to protocols and provide education to participating study sites • Provide direction to team members to improve processes within the department and delegate tasks to team members for department projects and ensure team deliverables are met within the required timeline • Participate and contribute to the development of clinical protocols and case report forms