Overview
Remote
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 17 day((s))
Skills
Business Analyst
Validation Testing
Job Details
Business Analyst with Validation Testing
Required Skills & Qualifications:
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
- Proven experience (5+ years) in clinical quality assurance, software validation, or clinical systems QA.
- Strong knowledge of GxP guidelines, FDA regulations, and compliance standards (21 CFR Part 11, GDPR, HIPAA).
- Experience with clinical trial management systems (CTMS), electronic data capture (EDC), or Veeva Vault Clinical.
- Proficiency in QA methodologies, test planning, execution, and defect tracking.
- Familiarity with automation tools and scripting is a plus.
- Excellent analytical, communication, and documentation skills.
- Ability to work collaboratively in cross-functional teams and handle multiple priorities.
Preferred Qualifications:
- Experience with validation of cloud-based clinical applications.
- Knowledge of risk management and quality management systems (QMS).
- Certification in quality assurance or clinical research (e.g., ASQ CQE, SOCRA, or ACRP).
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