Performance Evaluation Studies Expert

Performance Evaluation Studies Expert

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Hi there, who are you? 

Are you excited about science and technology? Do you love to dig into scientific data to investigate the performance of that new diagnostic test? Do you enjoy coordinating and making sure the job gets done according to plan? Are you looking for a job that allows you to help other people and work in a team of dedicated peers? Would you like to help IVD manufacturers to bring high quality products to the market?

Then we’re looking for you!
 

Who are we? 

Qarad, part of the QbD group, is a fast-growing consultancy company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. 
Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. We help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). We are also authorized representative for non-EU manufacturers and offer a unique solution for e-labelling, currently used by multi-billion-dollar medical device and IVD companies.
 

What are your responsibilities?

  • 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

 

Who are we looking for?

  • 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 are a strong communicator, decision maker and problem solver
  • You are administratively skilled, highly motivated to reach your goals and eager to learn
  • You enjoy working in an international environment
  • You are organized, flexible and customer focused

What does Qarad, part of the QbD group, offer you?

The QbD group is a healthy international company with strong growth ambitions (organic and inorganic). In addition to a competitive salary package, we can offer you:

  • The chance to acquire a broad knowledge in the fast-growing area of in vitro diagnostics
  • A company with a clear strategy and ambition
  • The opportunity to use and develop your skills in a world class team of specialists
  • Standing still means going backwards. With our extensive training package and our periodic knowledge-sharing moments, we offer you many opportunities to continuously learn, to expand or specialize your knowledge and skills and to gain new expertise
  • Thanks to our flat organization, we have short communication lines
  • You’ll work in an award winning company:
    • Our CEO, Bart Van Acker, became Flemish Young Entrepreneur of the year 2019, which means that you’ll be part of a vibrant, entrepreneurial organization.
    • We were elected as Best Managed Company by Deloitte in 2020 & 2021
    • We hold the Baanbrekende Werkgever 2022 certificate (Pioneering Employer) 
    • We are nominated as Trends Gazelle 2022 – Large Companies
  • Working in a value driven and data driven company where a people centric approach and business go hand in hand
  • We can only put the best of ourselves in our daily work when you also have some fun in the meantime and can build sustainable relationships with your colleagues and partners. We take care of JOY: Trans Alpes Nice Genève with our cycling team, triathlons, (trail) runs, parties and after works, our legendary annual weekend, charity events,… Get to know your colleagues outside the work environment!
  • In short… We go and 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!

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