Clinical Data Analyst / Technical SME - Databricks & AWS
Job Description
Role: Clinical Data Analyst / Technical SME – Databricks & AWS
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Location: Jersey City, NJ
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Type: Contract W2, C2C
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Rate: $60-65/Hr on C2C
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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.
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**🔹 Key Responsibilities**
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**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.
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**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.
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**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.
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- Prepare and maintain validation documentation, including:
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- System Assessments and Validation Plans
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- User Requirements and Functional Specifications
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- IQ/OQ/PQ and UAT Test Protocols
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- Requirements Traceability Matrix (RTM)
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- Validation Summary Reports
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**🔹 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