
Master Data Configuration Specialist
4 days ago
As a Clinical Data Configurator, you will be responsible for creating and reviewing data specifications as per industry standards. Your primary objective is to ensure that all programs are compliant with SOPs and project-specific guidelines.
- Create and/or review derive data specifications as per SDTM, ADaM datasets, and pooled analysis (ISS/ISE) datasets.
- Develop and validate analysis datasets, tables, listings, and figures for safety and efficacy parameters.
- Understand and comply with ICH-GCP guidelines, core operating procedures, and work instructions.
- Ensure all programs are compliant with SOPs and project-specific guidelines.
- Provide support in developing ad hoc reports as required.
Key Responsibilities include:
- Maintaining quality and timelines of programming-related deliverables.
- Updating project-related documentation regularly.
- Tracking and following up on all issues raised.
Requirements include experience with R Programming/Python. The ideal candidate should have a strong understanding of data configuration and compliance requirements, as well as the ability to work effectively in a team environment and prioritize tasks to meet deadlines.
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Master Data Manager
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