Clinical Data Analyst / Technical SME – Databricks & AWS

Role: Clinical Data Analyst / Technical SME – Databricks & AWSLocation: Jersey City, NJType: Contract W2, C2CRate: $60-65/Hr on C2CWe 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**- Design, develop, and maintain scalable data pipelines using Databricks and AWS.- Implement ETL/ELT processes for data ingestion, transformation, and integration across multiple sources.- Document data transformation logic and translate business requirements into technical specifications.- Troubleshoot data integration, system, and operational issues.**Clinical Business Systems & Delivery**- Partner with Clinical Operations teams to gather requirements, evaluate business needs, and implement solutions.- Serve as the Technical SME for clinical applications, including **eTMF, EDC, CTMS, IRT, MDM, and Analytics**.- Own end-to-end delivery, including onsite/offshore coordination, implementation, and operational support.- Develop functional specifications, business requirements, process flows, and current-state/future-state documentation.- Coordinate with external vendors and oversee system support, maintenance, and SLAs.**GxP & Computer System Validation**- Support GxP Computer System Validation (CSV) activities for clinical applications and integrations.- Collaborate with Quality Validation teams to assess validation impact and change control requirements.- Prepare and maintain validation documentation, including:- System Assessments and Validation Plans- User Requirements and Functional Specifications- IQ/OQ/PQ and UAT Test Protocols- Requirements Traceability Matrix (RTM)- Validation Summary Reports**🔹 Key Skills**- Databricks | AWS | ETL/ELT | Data Integration- Clinical Systems: eTMF, EDC, CTMS, IRT, MDM- Clinical Operations & Business Systems Analysis- GxP | Computer System Validation (CSV)- IQ/OQ/PQ | UAT | Change Control- Vendor Management | Onsite/Offshore Delivery Coordination- Requirements Gathering | Technical Documentation