Initiate, train and coordinate clinical study activities that may include training of investigators on both the study protocol and the company’s technology. Preparation of clinical study documents including study protocols, CRFs, investigator brochures and other study documents. Preparation for clinical studies, including: investigator selection and investigator meetings, budget planning and review, contract preparation, vendor selection and site selection. Manage study activities that may include oversight of CROs, core labs, and/or other vendors, reporting on study status, and ensuring timely completion within budget. Train vendors and clinical sites to ensure adherence to the protocol and compliance with ICH/GCP Guidelines. Assist in preparation of clinical study reports for regulatory submissions and scientific publications.
The hands-on financial planning and analysis position is responsible for forecasting, budgeting, analysis, reporting and other related financial activities.
The Senior Software Engineer is responsible for developing, documenting, testing, and delivering software for a production medical imaging system. The Senior Software Engineer also contributes to research for future products and product features.