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About the Role
Lead clinical trial operations for a digital cardiology start-up, driving a voice-based Software as a Medical Device through FDA clearance and into routine care. This role is critical in ensuring patient safety, data integrity, and successful trial execution.
Responsibilities
- 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 travel to the US without Visa restrictions (e.g. ESTA-eligible)
Skills
- 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
Location
- Berlin headquarters
- US sites
- Remote
Work Type
- Full-time
- Hybrid
Experience Level
- 5+ years in clinical research
- 3+ years in US FDA-regulated devices
Education Level
- Degree in life sciences, nursing, medicine, biomedical engineering or a related field
- Advanced academic degree (e.g. MSc)
Salary/Compensations
- Competitive pay plus meaningful equity
Benefits
- Meaningful equity
- Access to Urban Sports Club
About the Company
- Digital cardiology start-up headquartered in Berlin and Boston
- Focused on developing innovative technology to improve outcomes for patients living with heart failure
- Has deployed a CE-marked remote patient monitoring platform across Europe
- Advancing a voice-based Software as a Medical Device designed to detect worsening heart failure
- Voice-based solution has received FDA Breakthrough Device Designation
- Pivotal FDA trial underway across 15+ sites in the US, Canada, and Europe
- Collaborates with leading academic institutions and healthcare systems, including Charité, the Mayo Clinic, Duke, and Harvard
- Mission: helping people with heart failure live longer, healthier lives through earlier detection and innovative digital care
- Dynamic startup with exceptional talent from Harvard, TUM, Meta and Stanford