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About the Role
Noah Labs is seeking an individual to own the operational execution of US and EU programs, including an FDA pivotal trial and a randomized pragmatic trial. This role involves direct site management, coordination with academic partners and vendors, and growing the clinical team. The position offers direct collaboration with senior leadership and exposure to the FDA dialogue shaping a new device category. Ideal for those who bring structure to ambiguity and are comfortable making decisions amid uncertainty.
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
- US sites
Work Type
- Hybrid
- Remote
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)
Benefits
- 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
About the Company
- Noah Labs is a digital cardiology start-up, based in Berlin and Boston.
- We already run a CE-marked remote patient monitoring platform deployed across Europe, and we’re now developing Noah Labs Vox, a voice-based Software as a Medical Device that detects worsening heart failure from short daily smartphone recordings.
- Vox holds FDA Breakthrough Device Designation, with our FDA pivotal trial underway across 15+ sites in the US, Canada and Europe.
- We partner with leading academic centers and health systems across Europe and the US, including Charité, the Mayo Clinic, Duke, and Harvard.
- Everything we do is anchored in one goal: helping patients with heart failure live longer, healthier lives.