Sanjivani Zade

I’m an eTMF Specialist with 3.7+ years of experience in clinical research, focusing on eTMF management, quality control, and trial documentation in global CRO environments. I ensure accuracy, completeness, and regulatory compliance by performing detailed quality control reviews in Veeva Vault eTMF, aligned to TMF Reference Model expectations.

I drive TMF reconciliation to identify and resolve missing, duplicate, or misfiled documents, and I manage quality issues end-to-end through documentation, tracking, follow-up, and timely closure. I strengthen inspection readiness by performing ALCOA+ and metadata quality checks, supporting audit-ready documentation for essential records such as FDA 1572s and IRB/IEC approvals.

Previously, as a Clinical Research Coordinator, I coordinated day-to-day trial activities in line with ICH-GCP and protocol requirements—supporting patient recruitment, screening, informed consent, visit coordination, EDC system maintenance, and timely query resolution. I bring strong cross-functional collaboration to ensure smooth study execution and I mentor junior team members on TMF best practices.