Business System Validation Associate Specialist

Job Description

Are you passionate about ensuring data integrity, regulatory compliance, and the successful delivery of business-critical systems? Join our team and play a key role in validating innovative data integration and automation solutions that support high-quality clinical and business operations.

The Business System Validation Associate Specialist, GDMS Data Integration and Automation is responsible for executing and documenting validation activities to ensure data quality, system integrity, and regulatory compliance within GDMS (Global Data Management & Standards). This includes performing standard and study-specific validation tests, maintaining audit-ready documentation, and preparing validation summary reports.

Responsibilities

Validation planning, strategy & readiness

• Perform data integrity and consistency checks across data pipelines, integrations, and automation workflows

Test execution, defect management, & issue resolution

• Execute standard and study-specific validation tests in alignment with established protocols and test scripts.
• Log, track, and retest defects in accordance with defect management procedures and timelines
• Participate in AI-testing and automation pilots, ensuring adherence to validation standards and documentation practices

Documentation, compliance & continuous improvement

• Record detailed test results, maintain traceable evidence, and ensure audit-ready documentation
• Prepare and maintain validation summary reports, ensuring completeness and compliance with internal and regulatory standards

• Familiarity with clinical data management systems / platforms, data integration environments, and cloud computing platforms
• Proficiency with GxP, computer system validation (CSV), and other regulatory guidelines
• System Development Lifecycle Management / computer system validation knowledge
• Good documentation and testing practices preferred
• Experience or familiarity with test management tools

• Communicate effectively (oral/written) with technical and business partners and external vendors; adapt style to audience and able to translate technical topics into plain language
• Prioritize tasks, meet deadlines, maintain clean documentation
• Provide clear, timely updates; ask clarifying questions; write concise notes/status
• Establish positive working relationships across functions; receptive to and incorporate feedback quickly
• Apply basic structured thinking to resolve straightforward issues; know when to escalate
• Eager to learn new processes/technologies
• Strong attention to detail; follow SOPs and respect data privacy/compliance norms

• Execution Excellence | Reliably complete routine, structured work using existing procedures; prompt, accurate, and compliant in execution; take action to achieve results beyond what is required 
• Talent Growth | Focus on self-development, openness to feedback, and quickly building skills; embrace continuous learning and actively identify new areas for growth
• Diversity, Equity, & Inclusion | Respect and appreciate diverse perspectives; serve as a good team citizen that contributes to overall team effectiveness; value differences and work effectively with individuals of diverse backgrounds  

• Non-Degree with a minimum of 2 years of experience working in relevant field validation / testing role

• [Minimum preferred] Associate's Degree with a minimum of 1 year experience working in relevant field validation / testing role

• Bachelor's Degree or Advanced Degree (Masters or Doctorate) with prior experience in relevant field preferred (not required)

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