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.
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