At Biomapas, I independently manage clinical trial sites in Armenia, conducting site selection, initiation, monitoring, and close-out visits. I apply RBQM principles to identify site risks and support compliance with protocol, ICH-GCP, sponsor requirements, and local regulatory expectations.
At ICON plc (FSP – Merck), I monitored oncology and immuno-oncology studies and achieved site activation in 78 days through a parallelized start-up strategy. I maintained approximately 95% TMF completeness and supported oncology response-assessment documentation using RECIST 1.1 and iRECIST.
Earlier, at ClinChoice, I monitored ophthalmology medical device trials, including glaucoma and MIGS studies. At Ontario Health / Cancer Care Ontario, I built a customized data collection tool using Forsta Decipher and REDCap, plus an MS Access tracking system for a colorectal cancer screening study.
