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Principal Clinical Data Standards Consultant

6-10 years
Not Disclosed
10 June 13, 2025
Job Description
Job Type: Hybrid 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

 

Job Summary:

ICON plc, a global leader in clinical research and healthcare intelligence, is hiring a Principal Clinical Data Standards Consultant for its Bengaluru office. This key role involves designing and maintaining clinical data standards, ensuring compliance with global regulations (CDISC, FDA, EMA), and collaborating with cross-functional teams to drive the success of clinical trials and submissions. Ideal for experienced professionals in clinical data management and pharmaceutical data standards.


Key Responsibilities:

  • Develop tools to implement and ensure compliance with CDISC, Sponsor, and ICON data standards.

  • Collaborate with global teams to define data collection strategies and standards for clinical trials.

  • Create and maintain training materials and documentation on CDASH, SDTM, ADaM, define-XML, and regulatory submission requirements.

  • Oversee development and upkeep of data management processes and tools.

  • Stay updated on industry trends, standards, and regulatory updates; ensure integration into ICON’s practices.


Required Skills & Qualifications:

  • Bachelor’s degree in Life Sciences, Computer Science, or a related field; advanced degrees preferred.

  • Extensive experience in clinical data management and data standards within the pharmaceutical or biotechnology industry.

  • Strong proficiency in CDISC standards including SDTM, ADaM, and regulatory requirements (FDA, EMA).

  • Excellent analytical, problem-solving, and attention-to-detail skills.

  • Strong communication skills and ability to work cross-functionally.


Perks & Benefits:

  • Competitive salary (specific range not disclosed).

  • Multiple annual leave options.

  • Wide range of health insurance plans for employees and families.

  • Attractive retirement planning options.

  • Global Employee Assistance Program (LifeWorks) for 24/7 wellbeing support.

  • Life assurance coverage.

  • Optional country-specific benefits (discounted gym memberships, childcare vouchers, health assessments, etc.).


Company Description:

ICON plc is a world-renowned clinical research organization, offering cutting-edge data solutions to global pharmaceutical, biotech, and medical device industries. ICON is committed to delivering excellence in healthcare innovation and quality clinical research.


Work Mode:

On-site – Bengaluru, India


Call to Action:

Ready to shape the future of clinical data standards? Apply now to join ICON as a Principal Clinical Data Standards Consultant and drive global impact in clinical research.