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Performance Evaluation Studies Expert (H/F/X)

January 29th 2024

QbD supports companies worldwide in the life sciences throughout the entire product lifecycle, from idea to patient. With more than 450 quality experts, QbD is your partner for advice and support.

Mission Description

  • As a Performance Evaluation Studies expert you will coordinate different performance evaluation studies to ensure that all related tasks are carried out in a timely manner and in agreement with protocols, contracts and relevant regulations and/or guidances:
    • Drafting of evaluation protocols
    • Training and monitoring of the study sites
    • Data source verification and data analysis
    • Compilation of performance study reports

You discuss the status of the projects with the customers and you communicate with the study sites to ensure a smooth, accurate and qualitative execution of the studies

Candidate profile

  • You have a Master’s degree in sciences or technology (biomedical sciences, biology, pharmacy,…) or equivalent by experience. A PhD is an advantage but not a prerequisite.
  • You have relevant experience in IVD or biotech industry (such as experience with assay development and (analytical & clinical) assay validation)
  • You preferably have experience in regulatory affairs or have worked in a quality-driven environment (ISO)
  • You have experience and affinity with study designs, scientific data analysis and reporting
  • You have excellent English verbal & written communication skills
  • You have (technical) writing skills and an analytical mindset without losing track of the bigger plan
  • You enjoy working in an international environment
  • A true QbD’er can be recognised 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 BS 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.

Offer

An attractive and complete salary package:

  • A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.

But most of all…

  • We offer sustainable careers and meaningful connections
  • We are a knowledge based company 
  • You’ll work for an award winning company: Best Managed Company (Deloitte award), Baanbrekende Werkgever, …

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.
  • You’ll get the chance to acquire a broad knowledge in the fast-growing area of in vitro diagnostics
  • 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!

Contact Details

Send us your CV and motivation letter and who knows, maybe you’ll find your #QbDream job.

https://qbdgroup.com/en/jobs/vacancies/performance-evaluation-studies-expert/