Clinical Trial Manager

noah-labs; Berlin; Hybrid; EUR 120.000 - 170.000; Vollzeit

Benefits dieser Stelle

Equity

Remote-friendly

Zusammenfassung

Noah Labs in Berlin is seeking an experienced clinical operations lead to own the US and EU programs, including the FDA pivotal trial and a pragmatic European study, working directly with the CMedO and investigators.

You will build the function, manage sites, coordinate academic partners, and ensure patient safety, data integrity and inspection readiness across international sites while bridging US and Berlin time zones.

Qualifikationen

• Degree in life sciences, nursing, medicine, biomedical engineering or 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.
• 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).

Aufgaben

• Lead trial start-up including site selection, agreements, and budgets.
• 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.

Kenntnisse

Clinical research

US FDA devices

SaMD trials

IRB lifecycle

Multicenter trials

FDA CFR 21

ICH-GCP

ISO 14155

HIPAA

EDC

eTMF

Problem solving

Stakeholder management

Patient safety

English fluency

Travel to US

Ausbildung

Life sciences degree

Tools

EDC systems

eTMF systems

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 and EU programs - 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 travel to the US without Visa restrictions (e.g. ESTA-eligible)

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 Berlin-based role with regular presence at study sites – up to 30% travel to the US in the first 12 months, less thereafter. Working hours bridge US and Berlin time zones.

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