• Extensive experience with Phases I - IV clinical trials, class I- III medical device trials, people and project management, data management, including implementation of multiple sponsor and military clinical study protocols, Department of Defense (DoD) regulations, GCPs, central, local and military IRB requirements; inspection support; site start-up regulatory documents and ICD review, approval and IRB submission; design of protocols, ICDs, MPs, SOPs, DMPs, CCGs, centralized data monitoring guidelines and study tools; EDC build and edit check testing; data listing, cleaning and lock; eTMF/ISF audits; training/mentoring new staff• Experience with eTMF (ELARA, Veeva Vault), CTMS, IVRS, and EDC (I*Net, OCRDC, Phase Forward InForm, Merge eClinical OS/IBM Clinical Development, Datatrak)• Knowledge of DIA TMF Reference Model, Risk Based Monitoring (RBM)• Clinical research therapeutic areas of experience: cardiovascular, central nervous system / psychiatry, dermatology, endocrinology, gastroenterology, infectious disease, neurology / pain management, ophthalmology (drug and device), pulmonology, rheumatology, urology, and phase I/PK in CNS