Clinical Data Strategist

2 days ago


Kannur, Kerala, India beBeeData Full time ₹ 8,00,000 - ₹ 14,00,000

Job Title: Clinical Data Strategist


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  • Create data specifications according to standards for SDTM, ADaM datasets, and pooled analysis (ISS/ISE) datasets.
  • Develop and validate analysis datasets, 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 adhere to 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 preferred.


Key Requirements:

  • Strong understanding of data management principles and regulatory requirements.
  • Ability to develop and maintain complex data specifications.
  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving skills.
  • Ability to prioritize tasks and manage multiple projects simultaneously.
  • Experience with data visualization tools.


Benefits:

  • Competitive salary package.
  • Opportunities for career growth and professional development.
  • A collaborative and dynamic work environment.


Others:

  • Compliance with relevant regulations and industry standards.
  • Continuous improvement of processes and procedures.


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