
Clinical Data Configuration Manager
5 days ago
Job Title: Clinical Data Specialist
This role involves creating and reviewing data specifications, developing analysis datasets, and ensuring compliance with industry guidelines.
The ideal candidate will have experience with R Programming/Python, excellent problem-solving skills, and a strong understanding of clinical data configuration and analysis dataset development.
- Data Specification Development: Create and review derive data specifications for SDTM, ADaM datasets, and pooled analysis datasets in accordance with industry standards.
- Analysis Dataset Development: Perform development and validation of analysis datasets, tables, listings, and figures for safety and efficacy parameters.
- Compliance and Quality Assurance: Ensure all programs are compliant with ICH-GCP guidelines, core operating procedures, and work instructions. Maintain quality and timelines of programming-related deliverables.
- Documentation and Reporting: Update project-related documentation regularly and provide support in developing ad-hoc reports as required.
- Issue Tracking: Track and follow up on all issues raised.
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