Job Description:

The Field Clinical Engineer (FCE) located in the US (preferably on the East Coast) will report to the company VP R&D.  The FCE will be responsible for supporting clinical sites and will be the primary point of contact for the sites’ clinical team. 

Main Responsibilities:

• Supporting clinical trials: site installation, case support, EDC etc.
• Manage and provide accountability for day-to-day operations of the study, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations.
• Edit check specifications, data analysis plan, and final study report, when applicable.
• Serve as primary Sponsor contact for operational project-specific issues and study deliverables.
• Maintain in-depth knowledge of protocol, therapeutic area, and indication.
• Establish strong relationships with site investigators and other KOLs.
• Conduct periodic site visits (engagement and management).
• Administrative clinical department support.

Qualifications:

• Bachelor’s degree in a health-related field; advanced degree in a health-related field preferred
• 3+ years of experience in the medical device arena
• 3+ years of Clinical Affairs / field clinical specialist
• Familiar with catheter lab/operation room environment
• Excellent written and oral English communication skills
• Good organizational and technical skills
• CT reading / ECG analysis skills
• Willing to travel overseas often

Personal skills:

• Excellent communication, presentation, interpersonal and problem-solving skills
• Ability to work independently as well as collaboratively in a start-up environment
• Work under time and pressure constrains
• Positive attitude