NL
Clinical Trial Operations Manager - Digital Cardiology and Heart Failure
Berlin, GermanyPosted 22 days agoFull-time
Business OperationsClinical Research & TrialsAI relevant
Company
Noah Labs
Location
Berlin, Germany
Employment type
Full-time
Seniority
Manager
Primary category
Business Operations
Secondary category
Clinical Research & Trials
Posted date
18 Mar 2026
Valid through
17 May 2026
At Noah Labs, we are scaling a remote patient monitoring platform with a special focus on cardiology applications. Our solution combines advanced medical hardware devices, e.g., ECGs, cardiac implants with an intelligent monitoring platform for cardiologists.
In collaboration with renowned partners such as Charité in Berlin, the Mayo Clinic and UCSF in the USA (and many more), we are developing Noah Labs Vox, a groundbreaking remote monitoring tool that use machine-learning based markers from the human voice to detect heart failure worsening earlier than ever before.
Our vision? To extend the lives of people with cardiac conditions and improve their quality of life.
As Clinical Trial Operations Manager, you will take operational leadership of our FDA clearance trial for Noah Labs Vox and oversee execution of multiple ongoing EU and US clinical studies. You will work closely with clinical investigators, CRO partners, medical team, product, and data science teams to ensure studies meet regulatory, scientific, and operational excellence standards.
This is a onsite role in Berlin with approximately 10–25% international and national travel.
Key Responsibilities
Lead clinical operations of the Noah Labs Vox FDA clearance trial, ensuring compliance with GCP, ISO 14155, and FDA expectations.
Plan and manage all operational aspects: site selection and initiation, training, enrollment, monitoring, data management, and site close-out.
Oversee CRO ensuring deliverables, budgets, and quality metrics are met.
Support protocol development and regulatory submissions (e.g. De Novo/510(k) package).
Manage multiple global trials in parallel, including Noah Labs’ ongoing observational and validation studies in Europe and the US.
Collaborate cross-functionally with medical, AI/data, and product teams to align study design with scientific and technical development.
Engage with principal investigators and KOLs, fostering long-term academic and clinical partnerships with leading institutions around the world.
Ensure audit readiness and proactive risk management across all studies.
Monitor study progress and budgets, prepare executive reports, and communicate risks and mitigation strategies to leadership.
Contribute to scientific dissemination, including abstracts, publications, and conference presentations.
Required Qualifications
Bachelor’s degree or higher in Life Sciences, Medicine, Biomedical Engineering, or a related field
5+ years of experience in clinical research with medical devices, diagnostics, or digital health technologies
2+ years of trial or project management experience, ideally within multicenter, international trials
Strong knowledge of GCP, ISO 14155, and FDA/MDR regulations
Proven experience managing CROs, budgets, and external vendors
Excellent written and verbal communication in English
Preferred Qualifications
Experience in cardiology or heart failure research
Familiarity with AI-based software as a medical device (SaMD) and remote monitoring technologies
Background in clinical operations for FDA submissions (De Novo or 510(k))
Advanced degree (MSc, PhD, MD) preferred
Key Competencies
Strategic and independent execution in complex, regulated environments
Creative and strcutured problem-solving and adaptability to fast-changing priorities
Strong collaboration and stakeholder management across global sites and senior KOLs
Deep commitment to patient safety, data integrity, and clinical impact
Benefits
🫀 The unique opportunity to positively impact the lives of millions of people. 🚀 A dynamic startup with a diverse team and exceptional talent from Harvard, TUM, Meta and Stanford. 💸 An attractive compensation package with the potential to receive company shares. 🎾 Access to Urban Sports Club to help you stay active and fit. 💻 A beautiful office in the heart of Berlin Mitte, complete with a high-end espresso machine, drinks, and much more.
Salary
Depending on your skills and experience, the role's compensation will lie between €50-80k.
Apply Now and be a part of our mission to transform heart failure management through cutting-edge technology and compassionate care.