Clinical Performance Studies Expert

📍 Location : Hybrid 🕓 Type : Full-time We are seeking a dynamic and experienced Expert in Clinical Performance Studies to join our team, specializing in In Vitro Diagnostics (IVD). In this role, you will be designing, executing, and overseeing clinical performance studies for in vitro diagnostic (IVD) products. You will be ensuring that clinical performance studies are executed efficiently, accurately, and in accordance with established protocols and contracts. You will play a key role in driving project success, maintaining high-quality standards, and building strong relationships with customers and partners. If you’re ready to make a significant impact in a role that combines scientific expertise, organizational skills, and customer engagement, we invite you to join our team and help us drive the future of clinical performance studies . 🏢 What you’ll be doing Organize and execute assigned Clinical Performance Studies , including protocol development, monitoring activities and reporting. Protocol Development : Develop study protocols and project plans while ensuring alignment with project objectives, budget and regulatory requirements. Data Analysis & Reporting : Analyze complex clinical performance data, interpret results and draft high quality clinical performance study documentation. Regulatory Compliance : Ensure all studies are conducted in compliance with international regulations, including IVDR, ISO 20916, and other relevant guidelines. Collaboration & Communication: Work closely with internal teams, customers, and clinical sites to ensure successful study execution and data integrity. Training and monitoring: Provide training to study sites and conduct monitoring activities 💪 What you bring Bachelor’s, Master’s, or Ph.D. in a relevant scientific discipline (e.g., Biomedical Sciences, Biotechnology, Bioscience Engineering, …). Minimum 3 years of experience with development activities of IVDs Good knowledge of IVD clinical performance study design , implementation, and regulatory requirements (e.g. IVDR, ISO 20916). Expertise within any of these fields is preferred: infectious diseases (incl. knowledge of Common Specifications) or oncology Fluent in English , any other language are a plus. Attention to Detail: Ensures accuracy in study protocols, data analysis, and report writing. Analytical Skills : Proficient in data analysis and interpretation with experience in using statistical software tools. Problem-Solving and adaptability Customer Focus : Understands customer needs and delivers results that meet expectations. Excellent written and verbal communication skills , with the ability to write concise documentation and discuss project activities with diverse audiences. Strong organizational skills and ability to manage multiple projects simultaneously. 💡 What’s in it for you? QbD Group offers you an attractive and competitive salary package , that will be tailored to individual needs, considering legal requirements and local laws and regulations. Join us to build a sustainable career , where job security is ensured, and lasting, meaningful connections are formed. As we’re a knowledge-based company , you’re guaranteed to embark on a continuous journey of learning and development. Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together 🫵 Who you are Our culture is driven by values If this sounds like you, you’ll fit right in: You’re resilient and tackle challenges with a positive mindset You’re curious and always up for learning something new You have a no-nonsense approach honest, clear, respectful You’re innovative and bring ideas, not just opinions And above all, you’re serious about your work, but not too serious about yourself ✨ About us We support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma. We believe in JPEG : Joy. Partnership. Going the Extra Mile. Getting Things Done. You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger. 📩 Interested? Let’s talk. Send us your CV and motivation letter. You could be the next one to join the QbD family.