Clinical Trial Manager

Noah Labs; Berlin; Remote; Vertraulich; Vollzeit

Benefits dieser Stelle

Meaningful equity

Zusammenfassung

Noah Labs, a digital cardiology start-up, seeks a clinical operations lead to own the US FDA pivotal trial and European MDR investigations, coordinating sites, investigators and vendors.

You will work remotely in the US with regular visits to study sites and occasional travel to Europe, reporting directly to the CMedO and collaborating with regulatory, product and R&D teams.

Qualifikationen

• Bachelor-level or higher degree in life sciences or a related field.
• Minimum of 5+ years in clinical research, incl. 3+ years in US FDA-regulated devices.
• Experience with SaMD clinical trials and IRB lifecycle processes.
• Experience leading multicenter US trials from start-up through enrollment.
• Familiarity with 21 CFR Parts 812, 50, 56 and 11; ICH-GCP; ISO 14155; HIPAA.

Aufgaben

• Lead trial start-up including site selection, agreements, budgets, IRB submissions and site initiation.
• Drive enrollment and protocol adherence across sites with investigators and coordinators.
• Own the monitoring strategy and conduct monitoring visits (remote and on-site).
• Manage study budgets, timelines and risk registers; report to CMO.
• Oversee eTMF, EDC data cleaning, and protocol deviations.
• Ensure audit readiness (FDA BIMO, IRB) and maintain sponsor SOPs.

Kenntnisse

Clinical research experience

US FDA-regulated devices

SaMD trials

IRB submissions

Cross-functional collaboration

Ausbildung

Life sciences, nursing, medicine, or biomedical engineering degree

Tools

EDC systems

eTMF systems

Regulatory compliance tools

Jobbeschreibung

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.

Tasks

The role

As Vox is now gaining traction and momentum in the US, you will own the operational execution of our US clinical program - the FDA pivotal trial (15+ sites, De Novo submission) and a randomized pragmatic trial embedded in routine care, as well as oversight of our European MDR investigations run out of Berlin.

We don't work with a full-service CRO. This means you're not managing a vendor relationship, you're building the function itself, the one Noah Labs scales on after clearance. You'll manage sites directly, coordinate the academic partners and specialist vendors who provide independent trial functions, and help grow the clinical team as we go. You work directly with our CMedO, Clinical Research Lead, regulatory, product and R&D. You report directly to our CMedO and work face‑to‑face with investigators at leading US cardiology centers and inside the FDA dialogue that's shaping what a new device category even looks like.

If you like to bring structure to ambiguity and are comfortable making decisions amid uncertainty, this role is built for you.

In this role you will

• 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

What we're looking for

• 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)

Things to be aware of

This is a remote, US‑based role with regular presence at study sites – up to 30% travel in the first 12 months, less thereafter, plus occasional trips to our Berlin office. Working hours bridge US and Berlin time zones.

Benefits

$90–150K depending on experience, 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

Fully remote setup in the US with regular visits to our Berlin headquarters

Direct exposure to leading US cardiology centers and the FDA Breakthrough Devices process