Clinical Evaluation and Safety Manager

Shift Type









Job Title



Clinical Evaluation and Safety Manager





Education



Bachelor's Degree





Location



Remote (Virtual) - CN - CN
Stereotaxis - St. Louis, MO 63101 US (Primary)






Career Level



Manager





Category



Regulatory and Compliance





Date Needed By



05/31/2022





Job Type



Full-time





Travel



0 - 10%





Job Description



Position Summary:

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.

Essential Responsibilities:

• 
  

  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

  
  

Job Requirements



Qualifications & Skills:

• 
  

  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

  
  

Hiring Manager









Exemption Type









# of Hires Needed



1





Wage Amount