
Senior Clinical Data Specialist
5 days ago
The primary objective of this role is to configure and develop clinical data in accordance with stringent industry standards. This includes creating, reviewing, and deriving data specifications for SDTM, ADaM datasets, and pooled analysis (ISS/ISE) datasets.
We are seeking an individual with a keen eye for detail and exceptional analytical skills to join our team. The successful candidate will be responsible for the development and validation of analysis datasets, tables, listings, and figures for both safety and efficacy parameters.
This role requires a deep understanding of ICH-GCP guidelines, core operating procedures, and work instructions. You will be expected to ensure all programs are compliant with SOPs and project-specific guidelines while maintaining high-quality deliverables.
Responsibilities include providing support in developing ad hoc reports as required, tracking and following up on issues raised, and updating project-related documentation regularly.
The ideal candidate will have experience with R Programming or Python and be able to maintain timelines and quality standards.
Requirements- Strong understanding of ICH-GCP guidelines and industry standards
- Experience with data configuration and development
- Excellent analytical and problem-solving skills
- Ability to work under pressure and meet deadlines
- Proficiency in R Programming or Python
This is an exciting opportunity for an experienced Clinical Data Configurator to join our team and contribute to the development of innovative solutions. If you are a motivated individual with a passion for data analysis, we encourage you to apply.
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