Pooja User

At Clinvira Life Sciences, I coordinate end-to-end clinical data management for Phase II/III oncology and immunology trials. I design and configure eCRFs in Medidata Rave, build edit checks and C# custom functions, and lead database freeze and lock readiness.

Previously at Clininvent, I supported clinical data management across CNS, cardiovascular, and infectious disease studies. I developed validation specifications and plans, performed MedDRA and WHO-Drug coding, reconciled EDC, vendor, and safety data, and supported UAT and audit-ready documentation.

I bring more than six years of experience managing, cleaning, validating, and reconciling Phase I–IV clinical trial data. I use SQL, Python, SAS, VBA, and EDC platforms to deliver compliant, high-quality datasets aligned with CDISC, GCP, ICH, and regulatory requirements.