Senior Clinical Data Specialist

18 hours ago


Alleppey, Kerala, India beBeeClinical Full time ₹ 15,00,000 - ₹ 25,00,000
Key Clinical Data Configurator Role

A Clinical Data Configurator plays a vital role in ensuring the accuracy and quality of clinical data. The primary responsibilities include creating and reviewing data specifications, performing analysis dataset development and validation, and maintaining compliance with regulatory guidelines.

Essential Responsibilities:
  • Create and/or review derive data specifications as per the standards for SDTM, ADaM datasets, and pooled analysis (ISS/ISE) datasets.
  • Develop and validate analysis dataset, tables, listings, and figures for both 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.
  • Maintain quality and timelines of programming-related deliverables.
  • Update project-related documentation regularly.
  • Track and follow up on all issues raised.

To be successful in this role, candidates should have experience with R Programming or Python, excellent analytical skills, and the ability to work efficiently under tight deadlines.



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