Michael Glassman Email and Phone Number

Twenty years of clinical research expertise and experience leading clinical trials in multiple phases (Pilot,1-4), from start-up through close-out. Extensive experience in, Life-Sciences, Drug Development, Medical Devices, Biologics, IVD’s (Molecular Diagnostics and Immunoassays), FDA Regulations/ICH & GCP, GLP, and clinical trials conduct. CRA trained, nursing background, pre-clinical/molecular lab experience, familiarity with FDA submissions (IND, NDA, IDE, PMA, & 510K), and an advanced degree in Public Health (Epidemiology, Biostatistics, & Clinical Investigation). Experience in global trial startup and management across multiple countries. Proven leadership, problem solving and decision making skills to ensure effective and efficient trial execution on time and within budget/contractual parameters.Exceptional planning, and prioritizing multiple complex studies under aggressive timelines. Extensive expertise in leading cross functional teams to rapidly start up multiple countries, sites, and accelerated enrollment to meet and exceed study and sponsor driven timelines. Demonstrated skill and proficiency with delivery of key performance indicators (KPIs), proactive risk mitigation and effective oversight management. Therapeutic expertise in Cardiovascular, Renal, Pulmonology/COPD, Diabetes, Endocrine, Rheumatology, Regenerative Medicine/Wound Healing, Surgery, CNS, Orthopedics, Vaccines, Ophthalmology, Oncology, Biomarkers, & In-Vitro Diagnostics (immunoassays, molecular diagnostics, companion diagnostics).