Business Analyst - Clinical Validation Testing

Summary: The Business Analyst with Validation Testing role focuses on ensuring compliance and quality assurance in clinical systems through validation testing. The position requires extensive experience in clinical quality assurance and a strong understanding of regulatory guidelines. The candidate will collaborate with cross-functional teams to manage multiple priorities effectively. This role is remote and classified as outside IR35.

Key Responsibilities:

• Conduct validation testing for clinical systems to ensure compliance with regulatory standards.
• Collaborate with cross-functional teams to manage and prioritize testing activities.
• Document and communicate testing results and compliance issues effectively.
• Utilize QA methodologies for test planning, execution, and defect tracking.

Key Skills:

• 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.

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other