Responsibilities
- Direct the strategic development and optimization of clinical data systems to support regulatory compliance, advanced analytics, and operational excellence in global trials.
- Lead enterprise-level data standardization initiatives and architect scalable validation frameworks to proactively address systemic data issues.
- Build and maintain modular codebases using Python, R, SQL, and SAS, set coding standards, and mentor junior engineers.
- Oversee regulatory alignment with GCP and FDA 21 CFR Part 11, establishing robust documentation and audit trail protocols.
- Deliver actionable insights into trial performance and data quality through dynamic dashboards and analytics tools.
- Act as a strategic liaison across Biostatistics, Clinical Operations, and Regulatory Affairs, translating clinical requirements into scalable technical solutions.
- Lead the design of secure, high-performance databases and ETL pipelines integrating data from diverse clinical systems.
- Develop enterprise-level data mapping strategies that transform raw clinical data into standardized formats for high-impact analytics.
- Lead the adoption and governance of data standards across programs to ensure regulatory alignment and consistency.
- Design and implement robust, scalable validation frameworks that proactively detect and resolve systemic data issues.
- Serve as a strategic partner to Clinical Data Managers and cross-functional teams, driving continuous improvement in data integrity across global trials.
- Architect and maintain advanced, modular codebases using Python, R, SQL, and SAS to support complex data engineering workflows.
- Establish coding standards and mentor junior engineers in automation, reproducibility, and performance optimization.
- Lead compliance initiatives to ensure all data systems and workflows meet GCP, FDA 21 CFR Part 11, and evolving global regulatory requirements.
- Define documentation protocols and oversee audit trail governance to support inspection readiness and transparency.
- Develop and operationalize dynamic dashboards and analytics tools that provide real-time insights into data quality, trial progress, and operational KPIs.
- Translate complex datasets into actionable intelligence for clinical and regulatory stakeholders.
- Act as a strategic liaison between Clinical Data Engineering and Biostatistics, Clinical Operations, and Regulatory Affairs.
- Translate clinical and scientific requirements into scalable technical solutions that support study execution and data delivery.
- Lead the design and optimization of secure, high-performance relational databases and data lakes.
- Ensure infrastructure scalability, query efficiency, and data governance for large-scale clinical datasets.
Compensation
Competitive
Work Arrangement
On-site
Team
Collaborative
Data Standardization & Mapping
- Spearhead the development of enterprise-level data mapping strategies that transform raw clinical data into standardized formats for high-impact analytics.
- Lead the adoption and governance of data standards across programs to ensure regulatory alignment and consistency.
Data Quality Assurance
- Design and implement robust, scalable validation frameworks that proactively detect and resolve systemic data issues.
- Serve as a strategic partner to Clinical Data Managers and cross-functional teams, driving continuous improvement in data integrity across global trials.
Programming & Scripting
- Architect and maintain advanced, modular codebases using Python, R, SQL, and SAS to support complex data engineering workflows.
- Establish coding standards and mentor junior engineers in automation, reproducibility, and performance optimization.
Regulatory Compliance & Documentation
- Lead compliance initiatives to ensure all data systems and workflows meet GCP, FDA 21 CFR Part 11, and evolving global regulatory requirements.
- Define documentation protocols and oversee audit trail governance to support inspection readiness and transparency.
Reporting & Visualization
- Develop and operationalize dynamic dashboards and analytics tools that provide real-time insights into data quality, trial progress, and operational KPIs.
- Translate complex datasets into actionable intelligence for clinical and regulatory stakeholders.
Collaboration & Cross-Functional Support
- Act as a strategic liaison between Clinical Data Engineering and Biostatistics, Clinical Operations, and Regulatory Affairs.
- Translate clinical and scientific requirements into scalable technical solutions that support study execution and data delivery.
Database Design & Optimization
- Lead the design and optimization of secure, high-performance relational databases and data lakes.
- Ensure infrastructure scalability, query efficiency, and data governance for large-scale clinical datasets.
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