Clinical Data Analyst / Technical SME - Databricks & AWS
IVIDTEK INC
Role: Clinical Data Analyst / Technical SME – Databricks & AWS
Location: Jersey City, NJ
Type: Contract W2, C2C
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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. xhyhwjd
- 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
Vacancy posted 1 day ago
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