Clinical Trial Manager

AvomindGermany, United States

Apply now

Opens the original posting.

Apply now

Share job

Copy link or share on social media.

Apply on the original site

Companies in this catalog do not charge applicants. Never send money to apply.

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.

Loading job…

Jobs

Companies

Talents

Clinical Trial Manager

AvomindGermany, United States

Apply now

Opens the original posting.

Apply now

Share job

Copy link or share on social media.

Apply on the original site

Companies in this catalog do not charge applicants. Never send money to apply.

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)

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
Originally posted on Himalayas

Apply now

Opens the original posting.

Apply now