Clinical Business Analyst

3 - 8 years

5 - 15 Lacs

Posted:8 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

  • Contribute to the design and implementation of AI augmented clinical data products (Protocol, ICF, CSR, etc.) and GxP-validated content generation for

    SDTM, ADaM, and TLG.

  • Support development of Agentic AI solutions for specifications, data mapping, and metadata-driven workflows.
  • Assist in delivering analysis-ready datasets for submission use cases.
  • Collaborate in Agile projects, documenting requirements, writing user stories, and maintaining backlogs using JIRA/Retina.
  • Participate in requirement discussions, creation of specifications, traceability, and user guides aligned with regulatory compliance.
  • Engage with cross-functional teams to support AI-driven biometrics initiatives and knowledge sharing.

Requirements

  • Bachelors degree in engineering, Pharma, Bioinformatics, or related; Masters preferred.
  • Experience in Life Sciences as Business Analyst or Data Analyst with knowledge of clinical data standards (CDISC SDTM, ADaM).
  • Exposure to AI/ML or LLM-based clinical data pipelines in a GxP-regulated environment.
  • Hands-on experience with JIRA/Retina and Agile methodologies, including writing user stories and defining acceptance criteria.
  • Programming exposure in Python, R, or SAS is an advantage.
  • Strong communication and collaboration skills to work effectively in global, multi-functional teams.

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