Aura Biosciences

Clinical Research

• Provide clinical trial management for ongoing and future clinical trials in ocular melanoma
• Function as the Clinical Trial Lead on at least one trial managed in-house or with a CRO
• Partner with cross-functional stakeholders (Clinical, Regulatory, Product Development)
• Manage, execute and drive various aspects of clinical trial conduct with cross-functional team and contracted vendors
• Manage and drive CRO activities and deliverables if a CRO is utilized
• Develop and implement clinical processes and procedures including site budgets and contracts, investigator payments, protocol compliance reporting, risk assessments and investigational product and device management
• Develop and maintain clinical trial documents including informed consent templates, study plans and manuals, newsletters and site communications
• Collaborate with Data Management Vendor to develop eCRF and completion guidelines and conduct user acceptance testing
• Oversee data entry timelines, query management, metric reporting, and periodic clinical review of eCRF data
• Provide oversight and management of regional CRAs including review of site visit reports and training records
• Oversee site and CRA adherence to SOPs, Good Clinical Practice and FDA regulations
• Manage the Trial Master File (TMF) and ensure audit readiness
• Manage study budget and finances within established tolerances
• Facilitate and manage productive team communication and collaboration, both internally and externally

Senior Clinical Trial Manager, Ophthalmology