Clinical Trial Operations Manager Digital Cardiology and Heart Failure
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Monthly Salary:
Posted on:
1 hour ago
Vacancies:
1 Vacancy
Job Summary
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.
Tasks
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 1025% 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.
Requirements
Required Qualifications
- Bachelors 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
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 roles 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.
Key Skills
- User Interface
- Competitive Analysis
- New Technologies
- Business developments
- Communication
- Content Management System
- Market Research
- Internet
- Youtube
- Digital Assets
- Digital strategy
- Social Channels
- Digital Forensics
- A/B Testing
- Analytics
About Company
Noah Labs is a Berlin-based medtech startup transforming heart failure care through cutting-edge AI and voice biomarker technology. We are developing NL Vox, an innovative solution in the research phase that aims to detect early signs of heart failure decompensation earlier than curre ... View more
