Clinical Trial Operations Manager – Digital Cardiology & Heart Failure at Chapter 2

Berlin, Berlin, Germany -

Full Time

Start Date

Immediate

Expiry Date

21 Jun, 26

Salary

80000.0

Posted On

23 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations Leadership, GCP Compliance, ISO 14155, FDA Requirements, Protocol Development, Study Design, Regulatory Submissions, CRO Management, Risk Management, Cross-Functional Collaboration, KOL Engagement, Data Science Alignment, Digital Health, Medical Devices, MDR Regulations, SaMD

Industry

Business Consulting and Services

Description

About Us At Chapter 2, we’re not just scaling businesses—we’re reshaping the future of talent acquisition with passion, loyalty, and an unwavering commitment to results. By blending people, processes, and cutting-edge technology, we’ve redefined the traditional RPO model, delivering faster, smarter, and more cost-effective solutions that exceed expectations. As a global powerhouse, our team spans the UK, South Africa, the US, and Germany, with India as the next frontier in our ambitious expansion. Having grown 1300% in just two years, we are unstoppable fuelling our momentum with honesty, collaboration, and a shared vision. We are relentless in our pursuit of excellence, embedding world-class talent, pioneering technology, and compelling employer branding into organizations across industries. Our approach isn’t just about recruitment—it’s about building long-term success for our clients. We are loyal to our clients, to our vision, and most importantly, to each other—because we know that true success is built together. Chapter 2 – A scalable talent solution. For more information, please watch the Chapter 2 Evolution 🎥🚀 https://youtu.be/Fiap-bVnscY Clinical Trial Operations Manager – Digital Cardiology & Heart Failure Location: Berlin, Germany Type of role: Permanent Sector: Digital Health / Medical Technology (Cardiology & AI) Working environment: Office-based with flexibility Breakdown of hybrid arrangement: Primarily onsite (flexibility available) Working days and hours: Monday to Friday, full time Salary: A competitive compensation package (€50,000 – €80,000) with potential for company shares Benefits: · MacBook · iPhone · Access to Urban Sports Club to support your wellbeing · A modern office in the heart of Berlin · The opportunity to positively impact millions of patients globally · A high-growth, mission-driven startup with an exceptional interdisciplinary team We are supporting an innovative digital health company at the forefront of transforming how heart failure is monitored and managed. Their platform combines medical-grade hardware with advanced machine learning, including voice-based biomarkers, to detect early signs of deterioration and improve patient outcomes at scale. In collaboration with leading institutions such as Charité (Berlin), Mayo Clinic, and UCSF, they are developing a next-generation remote monitoring solution that is redefining cardiology care. They are now looking for a Clinical Trial Operations Manager to take ownership of global clinical operations, including a pivotal FDA clearance trial, and play a key role in bringing this groundbreaking technology to market. This is a highly visible, hands-on role where you will operate at the intersection of clinical research, regulatory strategy, and product development within a fast-paced startup environment. Responsibilities: · Clinical Operations Leadership · Lead the operational execution of a pivotal FDA clearance trial, ensuring compliance with GCP, ISO 14155, and FDA requirements · Oversee multiple international clinical studies across Europe and the U.S., including observational and validation trials · Manage all aspects of trial delivery including site selection, initiation, training, enrollment, monitoring, and close-out · Own CRO relationships, ensuring delivery against timelines, budgets, and quality expectations · Ensure audit readiness and proactive risk management across all studies Trial Strategy & Execution · Support protocol development, study design, and regulatory submissions (e.g. De Novo / 510(k)) · Monitor study progress, budgets, and KPIs, providing regular updates to leadership · Identify risks and implement mitigation strategies across complex, multi-centre trials · Drive operational excellence across all clinical activities Cross-Functional Collaboration · Partner closely with medical, product, and data science teams to align clinical studies with product and algorithm development · Engage with principal investigators and KOLs, building long-term partnerships with leading global institutions · Contribute to scientific outputs including abstracts, publications, and conference presentations · Embed clinical and regulatory thinking across the organisation Required: · Bachelor’s degree or higher in Life Sciences, Medicine, Biomedical Engineering, or a related field · 5+ years’ experience in clinical research within medical devices, diagnostics, or digital health · 2+ years’ experience managing clinical trials or projects, ideally across international, multi-centre studies · Strong knowledge of GCP, ISO 14155, and FDA/MDR regulations · Proven experience managing CROs, vendors, and clinical budgets · Excellent communication skills, with the ability to engage both technical and clinical stakeholders · Willingness to be based in Berlin with 10–25% travel Strong Plus: · Experience in cardiology or heart failure · Exposure to AI-based Software as a Medical Device (SaMD) or remote monitoring technologies · Experience supporting FDA submissions (De Novo or 510(k)) · Advanced degree (MSc, PhD, or MD) Why This Role? This is a unique opportunity to take operational ownership of a pivotal clinical program within a cutting-edge digital health company. You will play a critical role in generating the clinical evidence required to bring a truly innovative cardiology solution to market, with direct impact on patient outcomes worldwide.

Responsibilities

The manager will lead the operational execution of a pivotal FDA clearance trial, ensuring compliance with GCP, ISO 14155, and FDA requirements across multiple international studies. Responsibilities also include owning CRO relationships, managing trial delivery aspects like site selection and monitoring, and supporting protocol development and regulatory submissions.