Lisa has 20 years of clinical trial management experience. She has effectively collaborated and conducted complex immunohistochemistry/in situ hybridization (IHC/ISH) companion diagnostics (CDx) for various automated oncology IHC/ISH indications, infectious disease assays, immunodiagnostic devices and microarrays. She has served as Clinical Operations Lead in Digital Pathology for primary staining and 510(k) IHC/ISH next generation instrument study designs for submission for Roche. She is experienced in managing teams effectively to meet study objectives, budgets, timelines and goals with complex study designs at global sites, including the United States, China, Singapore, Australia and European countries. Lisa is also a registered Histotechnologist (HTL) from the American Society for Clinical Pathology Board of Certification (ASCP BOC) and has proven success in lab management experience, including maintaining College of American Pathologists/Clinical Laboratory Improvement Amendments (CAP/CLIA) certifications, sequestering and qualifying formalin-fixed, paraffin-embedded (FFPE) and frozen tissue, reagent validation and managing junior technicians.
- Executing clinical study management and activities, including site identification, site qualification, site initiation visits, interim monitoring, close-out visits, Institutional Review Board (IRB) approval, site budget/contracting and electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) implementation within the expected timelines
- Collaborating with internal and external teams on the development of CDx study designs/strategies for Pre-Market Approval (PMA) submissions
- Skilled at various HTL techniques, such as microtomy, IHC, ISH and special stains manually or automatically supporting manufacturing quality control
- IHC CDx clinical study management for US clinical performance study
- eTMF management for infectious disease clinical performance study for Blood Culture Identification and Susceptibility Testing
- Review and development of a suite of clinical and data management standard operation procedures (SOPs)