Lead R&D Technologist - Clinical Data Handling and Transformation

10 - 15 years

5 - 15 Lacs

Posted:1 week ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

What You’ll Do:


  • Design and implement innovative solutions across Clinical Data Management and Analytics within R&D and Drug Development programs.

  • Contribute to strategy, assessment, and technology implementation initiatives as a techno-functional consultant in the clinical data domain.

  • Lead and participate in business process discussions with stakeholders, identifying requirements, defining user stories, and advising on clinical data handling, transformation, governance, and access controls.

  • Conduct client workshops, interviews, and working sessions (virtual and in-person) to elicit, validate, and document business and data requirements.

  • Author high-level and detailed user stories, define acceptance criteria, support backlog refinement, and review test cases to ensure alignment with business needs.

  • Collaborate closely with cross-functional delivery teams to produce and maintain Requirements Specifications, RTMs, functional designs, and other project artefacts.

  • Plan and facilitate Agile ceremonies and artefacts, including sprint planning, reviews, retrospectives, and daily stand-ups.

  • Perform business process modeling, data flow analysis, user experience modeling, and create high-level solution and architecture diagrams.

  • Act as a techno-functional liaison between business stakeholders and engineering teams, ensuring accurate translation of clinical and regulatory requirements into implementable solutions.

  • Support delivery in large, complex, GxP-regulated programs, providing guidance, issue resolution, and escalation support where needed.

  • Mentor and guide junior analysts and consultants, contributing to capability building, best practices, and the growth of the Business Analysis community.


 

What You’ll Bring:


  • Bachelor’s degree in Pharmacy, Life Sciences, Bioinformatics, Medicine, or a related discipline.

  • Master’s degree in Business Analysis, Engineering, Data/Computer Science, or related fields is preferred.

  • 6–10 years of experience in the Life Sciences / Pharmaceutical domain, working as a Business Analyst, Clinical Data Consultant, Solution Architect, or Data Analyst.

  • Strong experience across Clinical Data Management and Biometrics, including areas such as:

    • Discrepancy and issue management

    • Clinical Data Repositories (CDR)

    • Clinical data transformation and automation

    • Operational and clinical reporting



  • Hands-on experience in end-to-end Clinical Data Repository implementations is highly desirable.

  • Deep understanding of end-to-end clinical data management and analysis processes across drug development.

  • Experience delivering GxP-compliant solutions within large, regulated enterprise programs.

  • Ability to translate complex clinical and regulatory requirements into scalable, technology-enabled solutions.

  • Exposure to programming or analytical tools such as R, Python, or SAS is preferred.

  • Strong stakeholder management, communication, and consulting skills, with the ability to work effectively in global, cross-functional teams.

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