Clinical Data Configuration Expert

6 days ago

Belgaum, Karnataka, India beBeeClinicalDataSpecialist Full time ₹ 8,00,000 - ₹ 12,00,000

About the Position:

This role requires a highly detail-oriented professional with excellent problem-solving skills and experience in clinical data configuration.

The ideal candidate will have a strong understanding of SDTM, ADaM datasets, and pooled analysis guidelines to perform development and validation of analysis dataset, tables, listings, and figures for both safety and efficacy parameters.

Key responsibilities include creating and/or reviewing derive data specifications as per standards, ensuring all programs are compliant with SOPs and project-specific guidelines, and providing support in developing ad hoc reports as required.

Maintaining quality and timelines of programming-related deliverables is also crucial. This role involves tracking and following up on all issues raised, updating project-related documentation regularly, and adhering to ICH-GCP guidelines and core operating procedures.

A strong background in R Programming/Python is essential for success in this position.

  • Create and/or review derive data specifications as per the standards for SDTM, ADaM datasets and pooled analysis (ISS/ISE) datasets.
  • Perform development and validation of 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 the 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.
  • Experience with R Programming/ Python is essential.

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