Clinical Data Analyst / Technical SME – Databricks & AWS

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**

• 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