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Principal Clinical Data Standards Specialist

8-12 years
Not Disclosed
10 June 12, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Principal Clinical Data Standards Specialist at Novartis – Hyderabad, India

Job Summary

Novartis, a global leader in healthcare innovation, is seeking an experienced Principal Clinical Data Standards Specialist to join its R&D team in Hyderabad, India. This full-time position involves leading the development and implementation of industry-compliant clinical data standards, infrastructure solutions, and automation technologies that ensure scientific integrity and operational excellence in clinical trials and drug development.


Key Responsibilities

  • Lead the planning, development, and execution of clinical data standards and automation technologies.

  • Drive the implementation of data analytics reports and dashboards for optimal data review.

  • Author user requirements, functional specifications, and testing scripts.

  • Translate business needs into data models and guide development teams in translating business logic.

  • Coordinate cross-functional project resources to ensure timely delivery of data tools and solutions.

  • Conduct change management activities related to new data review tools and technologies.

  • Provide user training on new data standards and automation solutions.

  • Ensure adherence to Novartis policies, regulatory guidelines, and KPIs.


Required Skills & Qualifications

  • Bachelor’s/Master’s degree in a relevant scientific or technical field.

  • Strong expertise in:

    • Clinical Trials

    • Biostatistics

    • Metadata Management

    • Computer Programming

    • Automation Solutions

    • Statistical Analysis

  • Experience in project coordination, operations management, and cross-functional collaboration.

  • Ability to manage crises and work across cultural boundaries.

  • Proficiency in English (spoken and written).


Perks & Benefits

  • Opportunity to work with a global pharmaceutical leader.

  • Access to continuous learning and skill development programs.

  • Competitive compensation and comprehensive benefits package.

  • Inclusive and diverse work environment.

  • Chance to make a meaningful impact on global healthcare advancements.


Company Description

Novartis is a world-renowned healthcare company committed to improving and extending people's lives. With a robust pipeline and cutting-edge R&D, Novartis drives medical innovation across therapeutic areas, focusing on patient-centric solutions and breakthrough science.


Work Mode

On-site – Hyderabad, India


Call to Action

Are you ready to shape the future of clinical data standards with Novartis? Apply now to be part of a transformative R&D team that impacts patients worldwide.