Avomind→
Clinical Trial Manager at Avomind in Berlin, Berlin, DE
Skills
Job Description
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
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 travel to the US without Visa restrictions (e.g. ESTA-eligible)
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)
💵 Competitive pay plus meaningful equity
🫀 Bring a first-in-class digital biomarker through FDA clearance and into routine care
🚀 A dynamic startup with exceptional talent from Harvard, TUM, Meta and Stanford
🌎 Based at our Berlin headquarters with regular visits to US sites and the flexibility to work remotely
✈️ Direct exposure to leading US cardiology centers and the FDA Breakthrough Devices process
🎾 Access to Urban Sports Club to help you stay active and fit