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EDC validation expert Mechelen Belgium,  

SGS (company)


Posted on : 12 June 2017

Project Description

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 



Tasks: 
  • 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, &) 
    


Requirements:
  • 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 
 

Locations

Belgium Vlaanderen Mechelen

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