Our client is scaling a remote patient monitoring platform with a special focus on cardiology applications. Their 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), they are developing a groundbreaking remote monitoring tool that use machine-learning based markers from the human voice to detect heart failure worsening earlier than ever before.

Their 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 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 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 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

• 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.