Clinical Data Configuration Specialist

5 days ago


Guntur, Andhra Pradesh, India beBeeClinicalData Full time ₹ 40,00,000 - ₹ 80,00,000
Job Title: Clinical Data Coordinator Specialist

Job Description: We are seeking a skilled Clinical Data Configurator to join our team. The ideal candidate will have experience in creating and reviewing data specifications, developing analysis datasets, and ensuring compliance with ICH-GCP guidelines.

As a Clinical Data Configurator, you will be responsible for creating and/or reviewing derive data specifications as per the standards for SDTM, ADaM datasets, and pooled analysis (ISS/ISE) datasets. You will also perform development and validation of analysis dataset, tables, listings, and figures for both safety and efficacy parameters. Additionally, you will ensure all programs are compliant with SOPs and project-specific guidelines.

Responsibilities:
  • 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


Required Skills and Qualifications: To be successful in this role, you will need to have:
  • Experience with R Programming or Python


Benefits: This is an excellent opportunity to join our team and take your career to the next level. You will have the chance to work with a talented group of professionals and contribute to the success of our organization.

Others: If you are a motivated and detail-oriented individual with excellent analytical skills, we encourage you to apply for this exciting opportunity.

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