Clinical Research Manager (FDA-Regulated Devices) - Digital Cardiovascular Health

Our client is a digital cardiology start-up headquartered in Berlin and Boston, focused on developing innovative technology to improve outcomes for patients living with heart failure. It has already deployed a CE-marked remote patient monitoring platform across Europe and is now advancing a voice-based Software as a Medical Device designed to detect worsening heart failure through short, daily smartphone recordings.

Its voice-based solution has received FDA Breakthrough Device Designation, with its pivotal FDA trial currently underway across 15+ sites in the US, Canada, and Europe. The company collaborates with leading academic institutions and healthcare systems, including Charité, the Mayo Clinic, Duke, and Harvard. At the heart of its work is a clear mission: helping people with heart failure live longer, healthier lives through earlier detection and innovative digital care.

The Role:

• Lead trial start-up including site selection, agreements, and budgets, IRB submissions, site initiation and training
• Drive enrollment and protocol adherence across sites in close partnership with investigators and site coordinators
• Own the monitoring strategy and personally conduct monitoring visits, both remote and on-site, in addition to managing any contract monitors
• Own study budgets, timelines and risk registers, reporting directly to the Chief Medical Officer
• Run the operational backbone: eTMF, EDC, data cleaning, and protocol deviations
• Ensure audit and inspection readiness (FDA BIMO, IRB) and maintain sponsor SOPs
• Support the European investigations and regulatory compliance (ISO 14155, MDR)
• Author and maintain SOPs and work instructions (WIs) for clinical operations, monitoring, and data management