This will generally involve close supervision of external contract organizations who will have responsibility for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory function, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities. In depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Project, MS Publisher, MS Outlook, and MS Windows NT, Exposure to CTM systems, EDC systems (eClinical, Medidata RAVE, InForm) and Safety/ Pharmacovigilance databases (ARGUS).