Clinical Evidence Manager – Medical Device

Your work environment DIAGNOLY is a MedTech start-up based in Lyon, France, on a mission to improve fetal screening. Our AI-powered medical device software connects to ultrasound machines and analyses examinations in real time to help healthcare professionals improve examination completeness and help detect complex fetal anomalies before birth. As we expand internationally and accelerate the generation of clinical evidence around our technology, we are looking for a Clinical Evidence Manager to lead the operational delivery of clinical studies demonstrating the performance and clinical value of Fetoly. This is not a traditional pharmaceutical clinical-trial role. You will work at the intersection of clinical research, medical device software, clinical data and AI, in close collaboration with hospitals, investigators, our Data Science team and our Regulatory function. Here’s what joining Diagnoly looks like:
• Close, hands-on management that encourages autonomy while supporting skills development
• A privileged work setting in the heart of Lyon
• A key role in an innovative MedTech start-up with a strong mission
• A dynamic, collaborative team in a fast-growing environment, with a culture built on cohesion and high standards
• Competitive market salary (€48k
- €60K) with significant annual performance-based bonus
• “Cadre” status with a 218-day work year + RTT
• Quality health insurance and income protection coverage for you and your family, covered at 70% Your role Your mission is to turn clinical questions and real-world clinical data into robust evidence about Fetoly's performance and impact. You will lead the operational execution of clinical studies, from defining what needs to be demonstrated and what data are required, through clinical data acquisition and study delivery, to publication of the results. You will act as a key link between our clinical partners and Diagnoly's Medical, Regulatory and Data Science teams. 🧪 Clinical evidence & study design
• Contribute to the design of clinical studies evaluating Fetoly's clinical and workflow performance, including anomaly detection performance, examination completeness, standardisation and HCPs productivity.
• Translate clinical evidence objectives into study protocols, endpoints and data requirements, together with internal experts and external investigators.
• Ensure that studies generate evidence relevant to our clinical, regulatory and product objectives.
• Coordinate with external or internal biostatistical expertise for statistical analysis when required. 🏥 Clinical study execution
• Lead clinical studies end-to-end: site identification and selection, onboarding, study set-up, timelines, enrolment tracking and day-to-day sponsor operations.
• Establish and manage partnerships with hospitals, clinics and healthcare professionals in Europe and the US.
• Act as the main point of contact for investigator sites and ensure strong, efficient collaborations.
• Coordinate study activities with our Regulatory function and other internal stakeholders. 📊 Clinical data acquisition Clinical data are at the core of both our clinical evidence and the continued development of our AI technology.
• Define and coordinate the clinical data required for studies and R&D projects together with our clinical and Data Science teams.
• Oversee the acquisition of fetal ultrasound data from clinical sites.
• Ensure that collected data are complete, traceable, appropriately documented and usable for their intended clinical or research purpose.
• Coordinate data flows between clinical sites and internal teams while ensuring appropriate data protection and research requirements.
• Identify and resolve operational issues affecting data collection, quality or study timelines. You are not expected to perform biostatistical analyses yourself, but you should be comfortable working with clinical datasets, understanding how data support a clinical question, and collaborating with technical and statistical experts. 📝 Scientific evidence & publications
• Manage the scientific publication pipeline arising from Diagnoly's clinical studies.
• Coordinate manuscripts, abstracts and congress submissions with investigators and internal contributors.
• Help translate study results into clear clinical evidence supporting regulatory, scientific and appropriate product claims. 🔬 Cross-functional collaboration
• Work closely with our Medical Advisory Board, Regulatory function, Data Science team and Leadership.
• Bring clinical-site realities and study findings back into product and clinical strategy.
• Ensure alignment between clinical evidence generation, product development and company priorities.
• Occasionally travel across Europe and the US for site visits, investigator meetings and key scientific events. At Diagnoly, you will not simply coordinate clinical trials. You will help build the clinical evidence demonstrating how an AI medical device can improve prenatal ultrasound practice. Your best assets

Experience:
You have 5–7 years of experience in clinical research, clinical evidence generation or clinical study management, with a track record in medical devices and/or Software as a Medical Device (SaMD). You understand the specificities of generating clinical evidence for a medical device, from study design and clinical data acquisition through to clinical evaluation and publication. Experience with AI/ML-enabled medical devices, medical imaging, diagnostic software or digital health solutions is particularly relevant. Previous MedTech / medical device experience is expected. Candidates whose clinical research experience is exclusively in pharmaceutical drug development are unlikely to match the requirements of the position. Clinical evidence mindset: You can translate a clinical question into a structured study (defining objectives, coordinating protocols and endpoints with the appropriate experts, identifying the data required, and driving the project through to interpretable results). Biostatistics expertise is not required, but you should be comfortable discussing clinical data and study results with clinicians, Data Scientists and statistical experts. Medical device & data environment: You have a strong interest in the development and clinical validation of AI and software medical devices, along with solid knowledge of clinical data acquisition, data quality, and GDPR-compliant data handling. Project ownership: Self-driven, rigorous and comfortable managing several clinical sites and projects simultaneously, you know how to build effective relationships with investigators and clinical teams while keeping studies moving against objectives and timelines. Language & clinical environment: You are fluent in both French and English. Experience in ObGyn, fetal medicine, ultrasound, or medical imaging is a bonus, but what matters most is your drive to work hand in hand with clinicians, engineers, and scientists to produce the evidence that will advance prenatal care. Recruitment process If you're excited about generating clinical evidence for an AI-based medical device and working in a fast-growing MedTech environment, we'd love to hear from you. Please write to careers@diagnoly.com with your CV and a short explanation of why this position interests you. A Diagnoly team member will review your application. If

your profile
matches our needs, you will be contacted for an introductory phone call, followed by an HR interview, a take-home case to present to Diagnoly's Leadership team, and a final interview with the Leadership team. 🤝 Diagnoly is committed to diversity and equal opportunity in recruitment. We welcome applications from all qualified candidates, regardless of gender, origin or disability.