Role: Clinical Data Analyst / Technical SME – Databricks & AWS
Location
Jersey City, NJ
Type: Contract W2, C2C
Rate: $60-65/Hr on C2C
We are looking for an experienced **Clinical Data Analyst / Technical SME** with strong expertise in **Databricks, AWS, ETL/ELT, Clinical Systems, and GxP Computer System Validation (CSV)** to support clinical business operations and enterprise data initiatives.
** Key Responsibilities**
**Data Engineering & Analytics**
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Design, develop, and maintain scalable data pipelines using Databricks and AWS.
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Implement ETL/ELT processes for data ingestion, transformation, and integration across multiple sources.
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Document data transformation logic and translate business requirements into technical specifications.
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Troubleshoot data integration, system, and operational issues.
**Clinical Business Systems & Delivery**
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Partner with Clinical Operations teams to gather requirements, evaluate business needs, and implement solutions.
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Serve as the Technical SME for clinical applications, including **eTMF, EDC, CTMS, IRT, MDM, and Analytics**.
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Own end-to-end delivery, including onsite/offshore coordination, implementation, and operational support.
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Develop functional specifications, business requirements, process flows, and current-state/future-state documentation.
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Coordinate with external vendors and oversee system support, maintenance, and SLAs.
**GxP & Computer System Validation**
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Support GxP Computer System Validation (CSV) activities for clinical applications and integrations.
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Collaborate with Quality Validation teams to assess validation impact and change control requirements.
- Prepare and maintain validation documentation, including
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System Assessments and Validation Plans
- User Requirements and Functional Specifications
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IQ/OQ/PQ and UAT Test Protocols
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Requirements
Traceability Matrix (RTM)
- Validation Summary Reports
** Key Skills**
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Databricks | AWS | ETL/ELT | Data Integration
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Clinical Systems: eTMF, EDC, CTMS, IRT, MDM
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Clinical Operations & Business Systems Analysis
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GxP | Computer System Validation (CSV)
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IQ/OQ/PQ | UAT | Change Control
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Vendor Management | Onsite/Offshore Delivery Coordination
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Requirements
Gathering | Technical Documentation
