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 do we expect from you as a Clinical Performance Studies Expert?

• 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

Responsibilities + highlight in bold some key words

Who are we looking for?

• Bachelor’s, Master’s, or Ph.D. in a relevant scientific discipline (e.g., Biomedical Sciences, Biotechnology, Bioscience Engineering, …).
• At least 5 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.
• Communication Skills: 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.
• 
  
• Strong autonomy and sense for quality

A true QbD’er can be recognized by the following qualities:

• Resilient: Your strong and positive attitude helps you overcome any challenge
• Hungry for knowledge: You are always open to learning
• No non-sense mentality: you can be straightforward in a respectful way
• Innovative: You are constantly looking for new and better solutions
• (Not too) serious: your job is serious, but you don’t take yourself too serious.

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

Our promise to you:

• As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
• Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
• In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done!
  

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!