Senior Clinical Data Standards Consultant
Location: Bengaluru, Karnataka, India
Job Type: Full-time, On-site
Job Summary:
ICON plc is seeking a Senior Clinical Data Standards Consultant to join our Data Management team and contribute to the creation, maintenance, and implementation of clinical data standards. This role focuses on supporting data collection instrument development, applying industry standards, and ensuring regulatory compliance while collaborating across multiple functional teams.
Key Responsibilities:
Develop and maintain content in the Data Standards Catalog under guided supervision.
Update metadata definitions and specifications based on CDISC SDTM/CDASH standards and controlled terminology.
Participate in governance team meetings and offer input on standards.
Collaborate with senior specialists/managers to execute data standards strategies aligned with internal and external regulations.
Provide subject matter expertise (SME) in specialized areas as needed.
Support cross-functional stakeholders including Clinical, Biostatistics, Medical Writing, etc.
Contribute to internal or cross-functional Data Management initiatives.
Supervise and hold accountable CRO/FSP data managers and/or database developers where applicable.
Represent the Data Standards team in project meetings, governance sessions, and clinical study discussions.
Candidate Requirements:
Demonstrated foundational knowledge of Data Management and Data Standards.
Familiarity with 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards.
CDISC certification, SCDM certification, or Medidata RAVE certification is a plus.
Minimum 2 years of clinical data standards experience in biotechnology, pharmaceutical, or health-related industries.
Educational Qualification: Bachelor's degree in Science, Health, Computing, or a related field.
What ICON Offers:
Competitive base salary and region-specific benefits.
Generous annual leave entitlements.
Comprehensive health insurance options for you and your family.
Retirement planning support.
24/7 access to mental health and well-being services via TELUS Health.
Life insurance coverage.
Country-specific optional benefits such as childcare vouchers, gym memberships, subsidised travel, and more.
To learn more about our benefits: https://careers.iconplc.com/benefits
To request accommodation: https://careers.iconplc.com/reasonable-accommodations
At ICON, we value inclusion, diversity, and belonging. We encourage all interested applicants to apply, even if you don’t meet every listed requirement—your potential might be exactly what we’re looking for.
Estimated Salary: ₹10 LPA – ₹16 LPA (Based on market standards for similar roles in Bengaluru)
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