Senior Manager, Trial Master File (TMF)

Role: Senior Manager, Trial Master File (TMF) at Aura Biosciences, overseeing TMF strategy, governance, quality, and inspection readiness across clinical trials in ocular oncology. Responsibilities: establish TMF standards, develop SOPs, ensure timely and complete documentation, manage vendor relationships and system configurations (Veeva Vault), facilitate audits/inspections, and lead continuous improvement. Required qualifications: Bachelor's in life sciences or related field; 7+ years in clinical research with 4-5+ years in TMF management; proficiency with eTMF systems (e.g., Veeva); experience with CRO oversight and regulatory inspections; strong knowledge of ICH-GCP, global regulations, and clinical trial documentation. Preferred: advanced degree, experience in ophthalmology/ocular oncology, leadership or mentorship background. HighValue: focus on ocular oncology clinical trials, TMF systems, regulatory compliance, vendor management, and inspection readiness. Work setup: hybrid or remote, with ~20% travel for vendor meetings and audits.