
Artificial Intelligence Data Generation Expert
1 week ago
As an AI data generation expert, you will play a pivotal role in designing and implementing intelligent frameworks for the creation of synthetic test data.
Key Responsibilities:- Synthetic Data Automation
- Create data generation frameworks to produce synthetic clinical and operational datasets.
- Develop compliant datasets (SDTM, ADaM) for data transformation, analysis, and reporting workflows.
- Simulate domain-specific datasets with variability and referential integrity.
- Implement connectors for Define-XML, Pinnacle21 validation, and statistical programming workflows.
- AI/ML in Data Generation
- Apply generative AI techniques to model realistic clinical scenarios.
- Generate synthetic patient journeys across EDC, eCOA, CTMS, LIMS, and PV systems.
- Use AI-driven automation to simulate rare or complex cases for stress and edge-case testing.
- Data Governance & Compliance
- Evaluate and ensure adherence to regulatory standards including GxP, 21 CFR Part 11, HIPAA, and GDPR.
- Implement anonymization/obfuscation while maintaining clinical and statistical fidelity.
- Produce validation protocols and documentation for audit and inspection readiness.
- Collaboration & Integration
- Work with Clinical Data Management, Biostatistics, Pharmacovigilance, and Compliance teams to gather requirements.
- Embed data generation into CI/CD pipelines, trial simulations, and automated validation environments.
- Partner with SMEs to validate AI-generated datasets for regulatory acceptability.
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Artificial Intelligence Specialist
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SME - Generative AI Architect
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Artificial Intelligence Developer
1 week ago
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