Tammy has a unique viewpoint on In Vitro Diagnostic (IVD) studies due to multi-disciplinary experience as Project Manager, Clinical Quality Specialist, Clinical Study Site Manager and a Nurse that utilized IVD products. Tammy’s experience includes integral roles related to project development, management and execution of a major U.S. / EU IVD product launch and in developing immunoassay study protocols for entrance into the Canadian market.

She previously served at Radiometer for almost a decade where she held the roles Clinical Quality Specialist and Clinical Study Site Manager. Tammy has a Master of Business Administration (MBA), Bachelors of Science in Nursing (BSN) and a Registered Nurse (RN) degree, as well as several other nursing certificates.

Currently, Tammy manages the Global IVD Project Management Team at NAMSA, dedicated to supporting IVD Sponsors with dedicated project management support from proposal to project completion. 

CORE COMPETENCIES

• Global project management for product submissions through China NMPA, Health Canada, CE Mark, FDA 510k, BLA and COVID-19 EUA submissions.
• Clinical project management and leadership for: Companion Diagnostics (CDx), molecular diagnostics (MDx), Next Generation Sequencing (NGS), Immunoassays and Infectious Diseases.
• Regulatory project management experience leading projects for: regulatory assessments, pre-submissions, IVDR readiness and FDA pre-submissions.
• Experienced clinical research manager and project manager maintaining clinical study timelines, budget and client communications.

RECENT PROJECTS

• KRAS/BRAF/EGFR IVDR TF completions EU and clinical study support in U.S. (multiple cancers, including NSLC)
• Diabetes projects: POC glucose for NMPA submission; clearance obtained and repeat Client currently seeking additional POC glucose device for NMPA submission
• Infectious Disease projects: TB, Multi-Plex Respiratory Panel, Meningitis, COVID-19