• Manage the conduct of clinical studies in accordance with approved protocols and good clinical practices
• Responsible for clinical study start-up activities including study regulatory documents, study management documents, IRB submissions, site qualification, and site initiation
• Help prepare study protocols, informed consents, case report forms, instructions for use, and study training documents
• Help prepare training materials; educate and support investigators/site personnel
• Manage site/study enrollment and follow-up requirements
• Responsible for monitoring sites; hiring and managing monitors as applicable, ensuring data integrity, protocol compliance, completeness and accuracy for all case report forms and study documents
• CRO management as applicable
• Manage clinical regulatory documents
• Responsible for clinical data analysis; producing study clinical reports
• Management of data, database, and data entry personnel
• Responsible for quality control and verification of data
• Responsible for development and resolution of data queries
• Responsible for adverse event evaluation, reporting, tracking, and reconciliation
• Responsible for database lock and release
• Management of on-site clinic including staffing, supply management, and policies/procedures
• Stay current on and apply appropriate internal quality initiatives including applicable SOPs or Work Instructions and external quality initiatives including FDA regulations, guidance documents and harmonized standards
• Participate in trade shows and other industrial conferences, and assist sales and marketing as needed
• Help develop training programs and educational material for physicians
• Maintain strong professional relationships with clinical investigators and medical key opinion leaders

• Principals only. Recruiters, please don’t contact this job poster.
• Please, no phone calls about this job!
• Please do not contact job poster about other services, products or commercial interests.