At Beam Therapeutics, I orchestrated end-to-end implementation and validation of cloud-based GxP platforms, including Veeva Vault eTMF and CTMS, 4G Clinical IRT, and OCELLOS. I managed project scopes, schedules, and cross-functional teams.
I partnered with the Quality Systems lead on GxP lifecycle documentation, from system impact assessments and requirements specifications through UAT protocols and validation summary reports. I also authored UAT test scripts with end users and coordinated vendor release assessments and change controls.
At Axogen, I authored project charters and implementation plans for executive governance and capital funding. I served as Technical Lead and SME across the SDLC for Veeva Vault eTMF, CTMS, RIM, CensiTrac, and RaveX EDC.
Earlier, I worked on Salesforce Health Cloud implementation and integration at Fresenius Medical Care, and led validation activities for Medidata Rave X EDC at Biogen. My work across life sciences and healthcare has included business requirements, system testing, and compliant system change management.
