Role: Senior Data Analyst / Clinical Data SME
Location: Cambridge, MA (Hybrid)
Experience: 10+ Years
Ideal profile
10 12+ years total experience, with approximately:
5+ years Data/ETL + 3+ years Databricks/AWS + 4+ years Clinical/Life Sciences + 3+ years GxP/CSV + 4+ years Technical SME/Business Systems Analysis.
Role Summary
We are seeking a Senior Data Analyst / Clinical Data SME to represent DDI as a technical and business SME supporting Clinical business functions. The role combines data analysis, Databricks/AWS data pipelines, ETL/ELT, clinical systems, business requirements, vendor coordination, and GxP Computer System Validation (CSV).
The ideal candidate should be comfortable working with both technical development teams and Clinical Operations/business stakeholders, while owning delivery across onsite and offshore teams.
Key Responsibilities
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.
Mandatory Skills
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
Preferred Skills
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
Success Metrics
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.
Important: A candidate who is excellent in Databricks/AWS but has no Clinical/Life Sciences and no GxP/CSV exposure would be a risky fit. Likewise, a Clinical Business Analyst with CSV experience but weak hands-on Databricks/AWS/ETL would also be incomplete.