Manages planning, design, conduct, and reporting of clinical studies in support of FDA Premarket Approval (PMA's), 510(k) submissions, ex-US product registrations, reimbursement strategies, clinical uptake needs, post-market studies, internal studies, and feasibility studies, as required. Specific clinical duties include developing clinical strategy, writing protocols, selecting and auditing clinical sites, developing support documentation for product registrations, and conducting appropriate training including Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). Interface with all principal investigators and their staff.