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EDC Test Analyst
EDC Test AnalystCelerion • Remote, Oregon, United States, 97458
EDC Test Analyst

EDC Test Analyst

Celerion • Remote, Oregon, United States, 97458
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EDC Test Analyst

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

As an EDC Test Analyst , you will serve as the critical link between database design and successful execution. You will validate clinical databases and systems that support clinical research, ensuring every study launches according to specifications.

Working in collaboration with Clinical Data Managers (CDM) and EDC developers, you will manually test clinical databases against study specifications, identify issues before they impact trials, and maintain project timelines from setup through reporting.

This is a remote role, working from home, anywhere in the United States.

What You'll Do

  • Perform comprehensive User Acceptance Testing (UAT) on clinical databases and related systems
  • Create and execute detailed test scripts based on database specifications
  • Coordinate with CDMs participating in UAT providing them with test schedules, test data, direction, and detailed test scripts in accordance with study timelines
  • Validate database libraries and system configuration changes per GxP requirements
  • Maintain complete validation documentation in compliance with departmental SOPs
  • Collaborate with multidisciplinary study teams to establish and meet timelines
  • Proactively identify risks and escalate issues to management and study team members
  • Communicate progress updates and coordinate testing schedules with stakeholders
  • Deliver all study deliverables on time per agreed timelines
  • Analyze system needs and evaluate workflow solutions
  • Participate in onboarding and validation of new systems and processes
  • Assist with the validation of upgrades to hardware / software including validation documentation development, review and execution.

What You Bring

  • Bachelor's degree in IT or related field, or equivalent internal or external experience in lieu of a degree
  • 3-5 years industry experience
  • Software validation or manual testing background
  • Exceptional attention to detail and organizational skills
  • Ability to juggle multiple projects simultaneously
  • Strong written and verbal communication skills
  • Proficiency in MS Office applications
  • Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part 11 is preferred

    • Why This Role Matters : Every test conducted, every issue identified, and every validation completed directly impacts the quality and reliability of clinical trial datadata that supports the development of new treatments for patients.

    Celerion Values : Integrity Trust Teamwork Respect

    Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

    PI45895dbd486b-30511-38892860

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    Test Analyst • Remote, Oregon, United States, 97458