The Clinical Evaluation and Safety Manager (CESM) will be responsible for oversight of the overall clinical safety surveillance of Stereotaxis's products. This includes evaluation and analysis of the clinical environment/product, ensuring clinical trial safety data is appropriately collected and reviewed, and working with Quality to ensure that Stereotaxis's products are appropriately monitored in the post-production environment.
Authors and manages all Scientific Literature Reviews, Clinical Evaluation Plans, and Clinical Evaluation Reports. With Quality, oversee global collection and analysis of product information to gain a complete picture of the risks and hazards of our products
Write narratives of serious adverse events and provide reports for regulatory body reporting, and safety committee review. Manage event review and preparation for adjudication for clinical trials with supporting Data Safety Monitoring Boards and/or Clinical Event Committees.
Timely assessment of adverse event coding for consistency and accuracy of coding, including communication with study physicians, clinical research team, and others to gather safety information, collect, prepare and file source documents, and resolve data queries on AE CRFs
Provide benefit-risk assessment for clinical studies; assist with Safety Plan development and implementation; aggregate safety monitoring of clinical trials
Review publications and complaints to meet compliance requirements
Assist in handling safety questions from IRB/IEC
Assist with updates to department SOPs to ensure compliance to MDR and ISO 14155:2020
Apply knowledge of ICH, FDA, and MDR regulations and guidelines affecting medical devices
Bachelor's Degree required, knowledgeable of therapeutic devices in the cardiovascular and electrophysiology space, with a broad exposure to clinical trials
Expertise with medical writing and deep understanding of the European MDR
Strong working knowledge of Good Clinical Practices, FDA regulations, ISO 14155 and 14971
Must remain flexible with changing demands and priorities in an entrepreneurial working environment is highly preferred
Ability to communicate clearly and concisely, detail oriented, strong organizational skills, responsive, independently driven
Legally authorized to work in the United States