Sr. Manager/Associate Director, Clinical Monitoring Oversight

Role: Lead and oversee global clinical monitoring activities for Aura Biosciences' ocular oncology trials, ensuring compliance with GCP, ICH, and regulatory standards. Primary objectives include managing monitoring strategies, site/vendor oversight, data integrity, patient safety, and inspection readiness across multiple regions. Responsibilities involve developing monitoring plans, managing CRO and CRA teams, reviewing visit reports and source data, addressing site performance issues, supporting audits, and contributing to study planning and risk management. Requirements: Bachelor's in life sciences or related field; 7–10+ years in clinical research with extensive monitoring experience; demonstrated leadership in managing CRA teams or vendors; strong knowledge of global regulations and risk-based monitoring methodologies; excellent communication and leadership skills. Preferred: experience in multiple therapeutic areas and trial phases, familiarity with EDC/eTMF/CTMS, regulatory inspection support, and project management certification. High-value specifics include a focus on ocular cancers, biologic or targeted therapies, Phase III registration studies, and a remote/hybrid work setup with travel. Cross-functional collaboration with clinical operations, data management, and regulatory teams is essential.