Aura Biosciences
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Biotech • Pharmaceutical
Provides strategic oversight and governance of Trial Master Files across clinical studies. Ensures complete, accurate, inspection-ready documentation compliant with ICH-GCP, regulations, and SOPs. Oversees eTMF systems, CRO and vendor relationships, TMF reviews, reconciliations, metrics, inspections, audits, training, and CAPA activities. Collaborates with clinical, regulatory, quality, biostatistics, data management, and pharmacovigilance teams, while potentially managing or mentoring TMF staff.
