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Principal Clinical Data Standards Consultant

3+ years
Not Disclosed
10 May 16, 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

Job Title: Principal Clinical Data Standards Consultant
Location: Bengaluru, Bangalore, Chennai (Hybrid: Office/Remote)
Job ID: JR128681
Department: ICON Full Service & Corporate Support – Data Standards


Company Overview:

ICON plc is a global leader in healthcare intelligence and clinical research. We are committed to fostering an inclusive environment that drives innovation, collaboration, and excellence in clinical development.


Role Summary:

As a Principal Clinical Data Standards Consultant, you will play a critical role in designing and managing the implementation of data standards that support high-quality clinical trials. You will work closely with cross-functional teams and contribute to the development of innovative therapies by ensuring data is collected, structured, and interpreted efficiently and accurately.


Key Responsibilities:

  • Develop tools to support the implementation and compliance with CDISC, Sponsor, and ICON standards

  • Collaborate with cross-functional teams to define clinical data collection strategies and standards

  • Create and maintain training and reference materials covering:

    • CDASH

    • SDTM

    • Controlled Terminologies

    • ADaM

    • Define-XML

    • Regulatory submission requirements

  • Manage and enhance data management processes and tools

  • Stay updated on industry trends and regulatory changes, and incorporate them into ICON’s practices


Qualifications & Experience Required:

  • Bachelor's degree in Life Sciences, Computer Science, or related field (advanced degrees are an advantage)

  • Extensive experience in clinical data management and standards within pharmaceutical or biotechnology sectors

  • Advanced proficiency in CDISC standards and knowledge of global regulatory requirements (e.g., FDA, EMA)

  • Strong analytical and problem-solving skills with attention to detail

  • Excellent interpersonal and communication skills to effectively work across teams


What ICON Offers:

ICON provides a competitive and comprehensive benefits package, supporting your professional and personal well-being:

  • Attractive salary with various annual leave options

  • Flexible health insurance packages tailored to individual and family needs

  • Strong retirement planning benefits

  • Global Employee Assistance Programme (LifeWorks) – 24/7 mental health and well-being support

  • Life assurance coverage

  • Flexible, country-specific optional benefits including:

    • Childcare vouchers

    • Bike purchase schemes

    • Discounted gym memberships

    • Subsidised travel passes

    • Health assessments

More information available at: ICON Careers Benefits


Commitment to Diversity & Inclusion:

ICON is dedicated to maintaining a workplace that values diversity and inclusion. All qualified applicants will be considered regardless of race, religion, gender, sexual orientation, disability, or veteran status.
Need accommodation? Submit a request here:
ICON Reasonable Accommodations

Think you're not 100% qualified? Apply anyway – we want to hear from you.