Data Configuration Expert

2 days ago

Thoothukudi, Tamil Nadu, India beBeeClinical Full time ₹ 10,00,000 - ₹ 20,00,000
Job Title: Clinical Data Specialist

We are seeking an experienced and detail-oriented Clinical Data Specialist to join our team. As a key member of our data configuration team, you will be responsible for creating and reviewing data specifications, developing analysis datasets, and ensuring compliance with ICH-GCP guidelines.


About the Role:
Our ideal candidate will have experience with R Programming/Python and a strong understanding of SDTM, ADaM datasets, and pooled analysis datasets. You will work closely with our data management team to develop high-quality programming deliverables and ensure timely project delivery.


Key Responsibilities:

  • Create and/or review data specifications as per standards for SDTM, ADaM datasets, and pooled analysis datasets (ISS/ISE).
  • Develop and validate analysis datasets, tables, listings, and figures for both safety and efficacy parameters.
  • Ensure compliance with ICH-GCP guidelines, core operating procedures, and work instructions.
  • Maintain quality and timelines of programming-related deliverables.
  • Track and follow up on all issues raised.

What We Offer:
As a Clinical Data Specialist, you will have the opportunity to work on challenging projects, develop your skills, and contribute to the success of our organization. We offer a dynamic and supportive work environment, competitive compensation, and opportunities for growth and development.


Requirements:
To be successful in this role, you will need:

  • A bachelor's degree in Computer Science, Statistics, or a related field.
  • Experience with R Programming/Python and data configuration.
  • Strong understanding of SDTM, ADaM datasets, and pooled analysis datasets.
  • Excellent communication and problem-solving skills.

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