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1 day ago
We are seeking a skilled Clinical Data Specialist to join our team. This individual will play a vital role in configuring and managing clinical data.
- Key Responsibilities:
- Data Specifications: Develop and review data specifications according to SDTM, ADaM datasets, and pooled analysis (ISS/ISE) datasets standards.
- Analysis Dataset Development: Create and validate analysis datasets, tables, listings, and figures for safety and efficacy parameters.
- Compliance: Ensure adherence to ICH-GCP guidelines, core operating procedures, and work instructions.
- Program Compliance: Verify that all programs meet SOPs and project-specific guidelines.
- Ad Hoc Reports: Provide support in developing ad hoc reports as needed.
- Quality and Timelines: Maintain quality and timelines of programming-related deliverables.
- Documentation: Regularly update project documentation.
- Issue Tracking: Track and follow up on all issues raised.
- Programming Skills: Proficiency in R Programming or Python is essential.
This position requires strong analytical and problem-solving skills, as well as the ability to work effectively in a team environment.
The ideal candidate will have experience working with clinical data and a solid understanding of data management principles.
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