David W. Liu

Skilled Clinical Operations / Inspection Readiness Manager with over 20 years’ experience in phase I-IV drug, medical device, and gene therapy studies. Involved in all aspects of study/site mgmt., initiations, monitoring, study termination/closeout, and TMF review. Experienced in selecting and managing vendors including CROs and CRAs. Experienced in planning and tracking trial timelines, budgets, recruitment strategies/enrollment. Experienced in working with KOLs and functional to write and implement protocols and amendments. Possess significant NDA, PMA filing and Inspection Readiness/Management experience. Experience in MOCK and actual Health Authority Inspections supporting the clinical team during and managing overall expectations during and post Inspection for any Inspection responses as needed. Experience in handling/managing rescue studies and transferring CRO’s and databases. Experience with auditing clinical sites and vendors for feasibility and clinical study Inspection Readiness for US/ROW Health Authority Inspections. Experience in Infectious Diseases, Respiratory, Oncology and Neuroscience therapeutic areas.