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EDC validation expert - Belgium  

SGS Life Science Services (company)


Posted on : 12 June 2017

Project Description

  • Our company is the world’s leading inspection, verification, testing and certification company. 
  • The company employs over 90 000 people and operates a network of more than 1 000 offices and laboratories around the world.. 
  • One of the business segments, Life Science Services, is a leading contract research organization (CRO) offering Clinical Research and Quality Control/Laboratory Testing Services to the pharmaceutical and biopharmaceutical industry. It provides outsourcing services on both the quality and safety of drug ingredients and the drug development process – from the early development stages until the commercialization of the finished product. 
  • In the spirit of continued growth and to help improve our business, we are seeking candidates for the following position (m/f): EDC Validation Expert – (e)CRF Designer 

  • Generate an (e)CRF based on the clinical trial protocol and/or predefined specifications 
  • Generate and maintain eCRF completion guidelines / eHelp text 
  • Generate and maintain functional specifications for the eCRF edit checks 
  • Create test steps for User Acceptance Testing 
  • Coordinate User Acceptance Testing 
  • Organize and provide EDC end-user training for internal company LSS employees, monitors, sites and sponsor users 
  • Program EDC edit checks 
  • Support integrations with other systems (eDiary, IWRS,…) 

  • Master degree in science, higher education in computer science or relevant experience 
  • Experience with EDC is an asset 
  • Fluent in English 
  • Strong organizational skills 
  • Positive, constructive, professional attitude towards colleagues, team members and clients 
  • Able to work in a young, flexible and dynamic group 
  • Good interpersonal and communication skills 
  • Eye for detail, very accurate and quality minded 
  • Excellent problem solving skills 
  • Able to set priorities and meet deadlines 
  • Stress resistant 
  • Pro-active 
  • Willing to learn