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 data—data 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.
About the job
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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 data—data 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.