At Biocartis, I lead MDx and CDx oncology and infectious disease assay studies supporting FDA and IVDR submissions for products including BRAF, EGFR, RAS, and SARS-CoV.
I've managed cross-functional teams, vendors, study timelines, budgets, feasibility, site selection, data cleaning, and top-line results while maintaining GCP/ICH compliance. I use Veeva Vault CTMS and eTMF to unify clinical information, documentation, and processes globally.
Previously at Abbott Laboratories, Roche-DOCs, and Radiometer America, I supported IVD and companion diagnostic studies, including 510(k) clearances, method comparison, precision, reproducibility, reference interval, and CLIA waiver studies. I've prepared validation plans, clinical protocols, feasibility questionnaires, regulatory packages, contracts, and budget proposals.
My clinical research background spans Phase I-IV domestic and international studies, site monitoring, investigator training, TMF management, data review, audit response, and regulatory submissions. I bring biomedical engineering and clinical research administration training to clinical operations and diagnostic product development.
