Clinical Data Engineer (Pharma/CRO, India-Remote)
Tasks
- Apply data modeling best practices
- Create inspection ready documentation
- Deliver curated datasets to analytics platforms
- Design scalable clinical data engineering solutions
- Design validation frameworks
- Develop T-SQL stored procedures
- Enable dashboards and operational KPIs
- Ensure FDA 21 CFR Part 11 compliance
- Ensure GCP compliance
- Implement data lineage for auditability
- Maintain SDTM and ADaM governance
- Map raw clinical data to CDISC standards
- Optimize SQL query performance
- Perform data quality checks and analysis
- Refactor code for reuse
Perks/Benefits
Skills/Tech-stack
21 CFR Part 11 | ADaM | Audit Trail | CDISC | CFR Part 11 | CRF Data | Common table expressions | Data Lineage | Data Modeling | Data Quality | Data Validation | Data Warehousing | Design Patterns | Dynamic SQL | FDA 21 CFR | FDA 21 CFR Part 11 | GCP | Part 11 | Python | R | Refactoring | SAS | SDTM | SQL | Star Schema | Stored Procedures | T-SQL | Window Functions
Education
Bachelor of Arts | Bachelor of Engineering | Bachelor of Science
Roles
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