Clinical Data Analyst / Technical SME - Databricks & AWS (Jersey City)

Part-time

IVIDTEK INC

Jersey City, NJ

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

Apply

Vacancy posted 14 hours ago

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