EDC Test Analyst
Celerion
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- 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.
Requirements
- 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
Benefits
- Celerion Values: Integrity, Trust, Teamwork, Respect
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
User Acceptance Testingtest scriptsvalidation documentationsoftware validationmanual testingsystem configurationworkflow solutionshardware validationsoftware validation documentation
Soft skills
attention to detailorganizational skillsproject managementcommunication skills