Clinical Trial Manager

The Company:

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

Requirements

• Degree in life sciences, nursing, medicine, biomedical engineering or a related field
• 5+ years in clinical research, including 3+ years in US FDA-regulated devices
• Familiarity with SaMD clinical trials
• Hands-on experience with the full IRB submission lifecycle: preparing and submitting packages, then amending documents like the CIP and ICF as the protocol changes.
• Hands-on experience taking a US multicenter trial from start-up through enrollment, and closing, on the sponsor side and without a full-service CRO
• Working knowledge of 21 CFR Parts 812, 50, 56 and 11, ICH-GCP, ISO 14155 and HIPAA; practical experience with EDC and eTMF systems
• Structured problem-solving and clear prioritization under shifting timelines
• Strong stakeholder management across academic sites, health systems and senior KOLs
• Uncompromising on patient safety, data integrity and inspection readiness
• Fluency in English
• Authorized to work in the US
• Nice to have: Cardiology or heart failure trials; pragmatic or health-system-embedded trials
• App-based or remote monitoring studies (patient onboarding, adherence, technical support)
• Contribution to a De Novo, 510(k) or PMA clinical evidence package
• Advanced academic degree (e.g. MSc)