Aura Biosciences

Medical Director

• Lead and oversee clinical monitoring activities across one or more global clinical trials
• Ensure studies comply with protocols, Good Clinical Practice (GCP), ICH guidelines, applicable regulations, and company SOPs
• Develop and implement global monitoring strategies, monitoring plans, and risk-based monitoring approaches
• Provide matrix oversight of internal CRAs and/or CRO monitoring teams across multiple countries and regions
• Review and approve site initiation, routine monitoring, and close-out visit reports
• Review monitoring performance, findings, action items, and follow-up activities
• Oversee source data verification, source data review, and centralized/remote monitoring activities
• Identify, escalate, and resolve site performance issues, protocol deviations, and data quality trends
• Partner on site selection, feasibility, and activation timelines
• Manage CRO and monitoring vendor relationships and deliverables
• Conduct co-monitoring and oversight visits to assess CRA performance
• Support site and vendor audits and inspections; ensure timely resolution of findings and CAPAs
• Maintain inspection readiness of the Trial Master File and monitoring documentation
• Track and report key risk indicators and quality metrics
• Contribute to monitoring-related SOPs, tools, and training materials
• Participate in recruitment, onboarding, training, and performance management of CRA staff and/or vendor teams
• Provide therapeutic-area and protocol-specific training to CRAs and site staff
• Represent monitoring/site management perspectives on cross-functional study teams
• Prepare and present monitoring updates, enrollment trends, and site performance metrics
• Contribute to protocol development, informed consent review, and study start-up activities
• Support monitoring budget and resource forecasting, including CRA staffing and travel

Senior Manager/Associate Director, Clinical Monitoring Oversight

Manager

• Establish and maintain TMF governance standards, including the Reference Model, filing structure, and metadata conventions
• Develop and maintain TMF-related SOPs, work instructions, and plans in alignment with ICH-GCP and applicable regulations
• Serve as the primary point of accountability for TMF inspection readiness across active and archived studies
• Provide TMF oversight for assigned studies, ensuring timely, accurate, and complete filing of essential documents
• Conduct or oversee TMF completeness and quality reviews and drive resolution of misfiled, missing, or duplicate documents
• Partner with Clinical Trial Managers and CRAs to ensure real-time filing practices
• Lead TMF reconciliation activities at key milestones
• Manage CRO and eTMF vendor relationships and oversee TMF-related deliverables
• Review and approve CRO TMF plans, transfer plans, and TMF health metrics/KPIs
• Lead TMF reconciliation and document transfer activities during vendor transitions or insourcing
• Serve as business owner or SME for the Veeva Vault eTMF system, including configuration, user access, and enhancements
• Partner with IT/Digital Quality on system validation, upgrades, and CTMS-eTMF integrations
• Develop and deliver eTMF user training
• Ensure TMFs remain audit- and inspection-ready and support regulatory inspections and audits
• Monitor and report TMF health metrics to clinical operations leadership and study teams
• Support CAPA development and implementation for TMF-related findings
• Line-manage and/or mentor TMF Specialists/Coordinators, if applicable
• Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, Pharmacovigilance, and Quality Assurance
• Represent the TMF function in study team meetings, vendor governance meetings, and process improvement initiatives

Senior Manager/Associate Director, Clinical Monitoring Oversight

Senior Manager, Trial Master File – TMF