Manasi User

I’m a Clinical Quality Assurance professional with 3.4 years of experience in GCP-compliant clinical research, regulatory compliance, quality systems, and audit support. I’m skilled in TMF review, CAPA, SOP compliance, clinical documentation, ICH-GCP, and FDA clinical research regulations, with a strong focus on data integrity and inspection readiness.

In my role, I conduct quality reviews and audits of clinical trial documents to ensure ICH-GCP, FDA, and Trial Master File (TMF) regulatory compliance. I perform quality monitoring, identify compliance gaps, and support effective CAPA implementation to keep study teams aligned and audit-ready.

I also manage regulatory documentation for clinical trial lifecycle processes, including IEC/IRB submissions, and support regulatory inspection readiness. I maintain SOPs, coordinate internal and external audits, track observations, ensure timely CAPA closure, and deliver ICH-GCP and SOP training to cross-functional clinical teams.