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Senior Clinical Data Standards Consultant

2+ years
Not Disclosed
10 July 18, 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

 

Senior Clinical Data Standards Consultant – Bangalore

Job Summary:

ICON plc is hiring a Senior Clinical Data Standards Consultant in Bangalore to support the development and governance of clinical data collection standards. This role offers a unique opportunity to work on global biometrics projects, ensuring regulatory compliance with CDISC, SDTM, and other key industry frameworks. Ideal for professionals with strong knowledge in data standards and a minimum of two years' experience in clinical data within pharma, biotech, or healthcare sectors.


Key Responsibilities:

  • Maintain and update metadata definitions and specifications per CDISC SDTM/CDASH guidelines.

  • Collaborate across departments to implement ICON's data standards strategy.

  • Participate in governance and project update meetings.

  • Provide subject matter expertise on clinical data standards topics.

  • Support Data Management and other stakeholders such as Biostatistics, Medical, and Clinical teams.

  • Oversee external CRO/FSP data managers or database development teams.

  • Contribute to cross-functional initiatives and continuous improvement of standards.


Required Skills & Qualifications:

  • Bachelor’s degree in Science, Health, Computing, or related field.

  • Minimum 2 years of experience in clinical data standards within pharmaceutical, biotechnology, or healthcare industries.

  • Foundational knowledge of data management and standards processes.

  • Familiarity with 21 CFR Part 11, ICH-GCP, and CDISC standards.

  • CDISC, SCDM, or Medidata RAVE certification is a plus.


Perks & Benefits:

  • Competitive salary (not specified in the job description).

  • Annual leave entitlements.

  • Health insurance plans for individual and family needs.

  • Retirement planning options.

  • Global Employee Assistance Program with access to over 80,000 professionals.

  • Life assurance.

  • Optional flexible benefits like childcare vouchers, bike schemes, gym memberships, health assessments, and more.


Company Description:

ICON plc is a global leader in clinical research and healthcare intelligence. With a strong focus on innovation and excellence, ICON offers data-driven solutions to pharmaceutical, biotechnology, and medical device companies worldwide. The company is committed to fostering inclusion, well-being, and career growth through a diverse and supportive work culture.


Work Mode:

On-site – Bangalore, India


Call-to-Action:

Are you ready to advance your career in clinical data standards with a global leader in clinical research? Apply now to join ICON’s team in Bangalore and shape the future of clinical data governance.