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Life Science Talent Logo Life Science Talent · IT - Software Development

Software Validation Tester

Denmark, København · Job Posted May 27, 2026
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Job Description

Studies&Me is a young health tech company focusing on building electronic outcome assessments (eCOA) elements for clinical trials. As a Software Validation Tester, you will play a pivotal role in ensuring high quality software tools used for data collection in clinical trials. The position is a 1-year maternity cover with possibility of extension or permanent position.

Job Responsibility

  • Driving, planning, and executing informal test activities
  • Defining URS/FRS, drafting validation documentation
  • Planning and writing validation test scripts
  • Executing and documenting validation tests
  • Setting up new clinical trials according to requirements and planning validation activities
  • Ensuring product and validation compliance with ICH-GCP and other regulatory requirements
  • Proposing and discussing new features for software solutions
  • Data reviews
  • Risk assessments
  • Incident resolution
  • Customer communication
  • Process optimizations
  • Updating SOPs and other internal documentation

Requirements

  • Professional experience in software validation, ideally within health tech
  • Experience using Jira and Github
  • Working according to GAMP-5
  • ICH-GCP and other regulatory guidelines on computerized systems
  • Fluent in English
  • Master's degree in health sciences/health tech/data science is a plus
  • Clinical trial experience is a plus
  • Pragmatic mindset
  • Eye for detail
  • Good communication and collaboration skills
  • Can-do attitude
  • Eager to learn
  • Structured and organized
  • Proactive problem-solver
  • Team player
  • High levels of complexity handling
  • Empathy
  • Stamina to execute and influence
  • Open-minded and flexible
  • Follow through on commitments
  • Keeps deadlines

Nice to have

  • Clinical trial experience
  • Master's degree in health sciences/health tech/data science

What we offer

Flexible work-life balance with possibility to work from home as agreed with management

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