Clinical Trial Manager

Avomind; Berlin; Hybrid; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Equity

Remote work flexibility

Urban Sports Club

Zusammenfassung

Avomind, a digital cardiology startup, seeks a senior Clinical Operations lead in Berlin to oversee trial start-up, enrollment, and monitoring across sites. You will manage budgets, timelines, and risk, ensuring FDA BIMO readiness and regulatory compliance for SaMD programs.

The role requires 5+ years in clinical research, including US FDA-regulated devices, and fluency in English. Based in Berlin with US travel and potential remote work flexibility.

Qualifikationen

• 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 IRB submission lifecycle (CIP and ICF).
• Experience leading multicenter trials from start-up through enrollment and close.
• Working knowledge of 21 CFR Parts 812, 50, 56 and 11; ICH-GCP; ISO 14155; HIPAA; EDC/eTMF systems.

Aufgaben

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

Kenntnisse

Clinical research

FDA-regulated devices

SaMD trials

IRB submissions

Stakeholder management

English fluency

Ausbildung

Degree in life sciences / nursing / medicine / biomedical engineering

Jobbeschreibung

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 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)

• 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