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 youre 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 youll 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

• Bachelors Masters 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.

Whats 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 were a knowledge-based company youre 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 everyones contribution and celebrate achievements together

Who you are

Our culture is driven by values If this sounds like you youll fit right in:

• Youre resilient and tackle challenges with a positive mindset

• Youre curious and always up for learning something new

• You have a no-nonsense approach honest clear respectful

• Youre innovative and bring ideas not just opinions

• And above all youre 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 wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.

Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.