Data Analyst / Clinical Data SME, Cambridge, MA (Hybrid)

Role: Senior Data Analyst / Clinical Data SME
Location: Cambridge, MA (Hybrid)
Experience: 10+ Years

• Design, develop, and maintain scalable data pipelines using Databricks and AWS.
• Develop ETL/ELT processes for data ingestion, transformation, integration, and data quality.
• Translate Clinical business requirements and data transformation logic into detailed technical specifications.
• Partner with Clinical Operations to understand business needs and recommend effective data/system solutions.
• Act as a technical SME for clinical systems including eTMF, EDC, CTMS, IRT, MDM, and Analytics.
• Document current-state and future-state processes, business requirements, functional requirements, and system specifications.
• Own end-to-end delivery while coordinating onsite and offshore teams.
• Work with internal development teams and external vendors to ensure successful implementation and delivery.
• Troubleshoot data, application, integration, and operational issues.
• Coordinate vendor support, maintenance activities, SLAs, and service delivery.
• Support implementation and integration of new Clinical technology solutions.
• Partner with Quality/Validation and business stakeholders to determine CSV/GxP validation requirements and impact.
• Support validation activities including System Assessments, Validation Plans, URS/Specifications, IQ/OQ/PQ/UAT testing, Traceability Matrix, and Validation Summary Reports.
• Maintain appropriate documentation for system changes, enhancements, implementations, and change controls.

• Min 3+ years hands-on with Databricks
• Min 3+ years hands-on with AWS / Cloud
• Min 5+ years hands-on with ETL/ELT and data pipeline development experience
• Min 5+ years hands-on with data transformation and integration
• Min 5+ years hands-on with SQL / data analysis skills
• Min 5+ years hands-on experience gathering and documenting business and functional requirements
• Min 5+ years' experience working as a Technical SME / Business Systems Analyst
• Experience coordinating onsite/offshore development teams
• Strong stakeholder and vendor management skills
• Min 3+ years hands-on experience with Clinical systems such as EDC, CTMS, eTMF, IRT, MDM, or Clinical Analytics
• Min 3+ years hands-on with GxP / Computer System Validation (CSV)
• Experience with validation documentation such as URS, validation plans, test scripts, traceability matrices, and validation summary reports

• Python
• AWS data services
• Databricks workflows / Delta Lake
• Data quality and governance
• Clinical/Pharmaceutical/Life Sciences domain experience
• Vendor management and SLA oversight
• Change control and regulated system environments

• 95%+ on-time delivery of assigned data, integration, and clinical system initiatives.
• Successful delivery and maintenance of scalable Databricks/AWS data pipelines with minimal production issues.
• 98%+ accuracy/completeness in critical data transformations and integrations.
• Requirements and technical documentation completed with minimal rework or clarification cycles.
• Timely resolution and escalation of operational/system issues in accordance with agreed SLAs.
• Successful coordination of onsite/offshore teams and vendors against project milestones.
• 100% completion of required CSV/GxP validation documentation for applicable system changes and implementations.
• Successful completion of UAT/validation activities with zero critical unresolved defects at release.
• Maintain strong compliance with GxP, validation, change-control, and documentation standards.