Clinical Research Associate

Clinical Research Associate ●       Full-time position ●       Barcelona, Spain. Hybrid-mode (3-4 office days) About Zoundream We are Zoundream, a dynamic, growing, and ambitious startup developing the world's most advanced technology for infant voice analysis, powered by Artificial Intelligence (AI) and sound recognition. We are a passionate, multidisciplinary team of scientists, engineers, and product visionaries, and our mature core technology is the world leading solution for the analysis of infant voice, trusted and used by the major juvenile brands worldwide (e.g., Philips Avent, Maxi-Cosi, Motorola Nursery). By analyzing newborn cries and vocalizations, Zoundream delivers powerful, actionable insights — not only interpreting infants' real-time needs, but also flagging critical risk patterns that serve as early indicators for health assessment. The Role Currently, we are expanding our team to reinforce a groundbreaking project aimed at supporting early detection of pathologies and neurodevelopmental conditions fully non-invasively through infant voice analysis. With ongoing projects in collaboration with multiple large corporate customers and hospitals worldwide, we are seeking a proactive, versatile, autonomous, and motivated Clinical Research Associate to coordinate our global pre and post market clinical studies and scientific dissemination to enhance our SaMD technology, providing top innovative digital health to every home. What You Will Do Your

key responsibilities
will include (but are not limited to): ●       Overseeing and managing pre and post market clinical trials in collaboration with clinical sites, academic collaborators, and Clinical Research Organizations (CROs), including the preparation and oversight of associated documentation, requests, and processes (e.g., protocols, informed consent forms, contracts, budgets, patient safety measures and logistics, IRB guidelines, ethical committees submissions). ●       Overseeing and monitoring the progress, quality and data collection of multicentric clinical trials using internal and EDC tools such as Castor. ●       Proactively identifying and engaging with hospitals, research institutions, healthcare providers, and other relevant organizations to establish collaborations that strengthen clinical trials, support research initiatives, and create synergies and new opportunities for clinical and scientific development. ●       Ensuring strict adherence to regulatory, ethical, and quality assurance guidelines, as well as global standards and compliance processes throughout clinical trials and medical device development and validation (e.g., GCP, ISO 14155, ISO 13485, and basic awareness of GDPR). ●       Collaborating cross-functionally with data scientists, engineers, software developers, and external partners to align clinical research objectives with product development goals. ●       Collaborating closely with the data analysis team on the clinical strategy, hypothesis definition, statistical analysis plans and interpretation of clinical results with scientific rigor. ●       Supporting the participation and/or sponsorship of scientific and industry events, aimed at identifying emerging trends, fostering collaborations, and enhancing the visibility and adoption of our technology within the healthcare ecosystem (e.g., hospitals, telemedicine platforms, and insurance providers). Which Skills Are We Looking For *(Must-Haves)
* *Qualifications &

Experience:
* ●       Doctoral degree (PhD) and/or Medical Degree (MD) in Biomedical Sciences, Bioengineering, Biotechnology, Health/Life Sciences, Epidemiology, Statistics, Neuroscience, Neuropsychology or related field. ●       Specialization and clinical experience in Pediatrics, Neonatology, Child Speech/ Language Development, Pediatric Neurology, or Developmental Psychology is a strong plus. ●       Proven experience (≥5 years) in clinical research and clinical trial management. Experience in medical devices, digital health, or Software as a Medical Device (SaMD) is a strong plus, particularly experience supporting clinical validation or regulatory approval of digital health products. ●       Fluency in English (both written and spoken) is required, as you will be part of an international and multicultural team. ●       Ability and willingness to travel (approximately 10–20% of the time). ●       Demonstrated experience in overseeing, managing, and executing ambitious research projects, multicentric clinical trials or observational studies, including collaboration with CROs and hospital research units. ●       Proven ability to manage relationships with external stakeholders — hospitals, investigators, regulatory consultants, CROs — ensuring alignment and quality in execution. ●       Experience contributing to the preparation and review of clinical and study-related documentation, such as protocols, informed consent forms, and clinical study reports, with strong attention to scientific rigor, quality, and compliance. Familiarity with clinical evaluation and related medical device documentation is a strong plus. ●       Working knowledge of GCP and ISO 14155 and their application to clinical trials. Familiarity with medical device regulatory and quality frameworks, including MDR/CE, FDA, QMS, and GDPR, is a strong plus. ●       Innovative thinking able to propose and execute new strategic ideas in digital health and medical device integration, identifying research trends and partnerships aligned with Zoundream’s long-term goals. ●       Skilled at collaborating across disciplines (engineering, data science, product) and building trust with clinicians, regulators, and partners. ●       Proven ability to identify and pursue funding opportunities (e.g. grants, technology integration projects, alliances, reimbursement programs) is a plus. What Type of Person You Are ●       Highly self-motivated and proactive, always looking for new tasks and challenges, bringing enthusiasm and inspiration with a solution-driven approach. ●       A “player-coach” mentality – capable of combining strategic thinking with hands-on execution and taking ownership from planning through to delivery. ●       Autonomous, assertive, organized and able to work with minimal guidance, ensuring deadlines and prioritization, with strong attention to detail and a structured mindset. ●       Ambition attitude with effective multitasking and time management skills. ●       Adaptable to change, versatile and excited to embrace risks and disruption in a dynamic environment. ●       Eager to embrace startup culture and thrilled to contribute to the success of innovative, high-impact technology changing the world. ●       Driven by a passion to make a meaningful impact, committed to advancing science and improving healthcare and society. ●       Most importantly: you are a great team player and networker who thrives in a collaborative, vibrant environment.

What We Offer
●       The opportunity to be part of a high-tech, mission-driven startup at the forefront of global infant voice analysis technology using advanced AI and sound recognition. ●       Work with a passionate, ambitious, and diverse team dedicated to redefine infant care through technology. ●       A collaborative, innovative and dynamic environment with direct influence on product development and company direction. ●       Opportunities to grow professionally contributing your ideas and innovations while taking on new challenges and responsibilities. ●       Play an impactful key role in developing and improving products that directly impact patients' lives and drive advancements in healthcare. ●       A competitive compensation package: ●       Salary range: €48,000 – €58,000, aligned with your experience and expertise. ●       Stock options €10,000 – €15,000, with usual 4 years vesting / 1 year cliff, to share in the company's success and growth. ●       Flexibility to maintain a healthy work-life balance. To Apply: Please submit your CV detailing your relevant experience to research@zoundream.com *Do not hesitate. Join us and let’s revolutionize the future of infant care together*