Senior Clinical Data Specialist

2 weeks ago

Gandhinagar, Gujarat, India beBeeData Full time ₹ 8,00,000 - ₹ 10,00,000

Clinical Data Configurator Job Description

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We are seeking a highly skilled Clinical Data Configurator to join our team. The ideal candidate will have experience in creating and reviewing data specifications, developing and validating analysis datasets, and ensuring compliance with regulatory guidelines.

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Responsibilities: \
  • \
  • Create and/or review data specifications as per standards for SDTM, ADaM datasets, and pooled analysis (ISS/ISE) datasets\
  • Develop and validate analysis datasets, tables, listings, and figures for 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\
  • Experience with R Programming/Python\
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Requirements: \
  • \
  • Strong understanding of clinical data management principles and practices\
  • Excellent analytical and problem-solving skills\
  • Ability to work independently and collaboratively as part of a team\
  • Effective communication and interpersonal skills\
  • Proficiency in R Programming or Python\
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Benefits: \

This role offers a competitive salary and a range of benefits, including professional development opportunities, flexible working arrangements, and a supportive team environment.

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