Job Title: Principal Clinical Data Standards Consultant
Company: ICON plc
Location: Bangalore / Chennai / Bengaluru (Hybrid: Office/Remote)
Job ID: JR128621
Department: Full Service & Corporate Support – Data Standards
About the Role:
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Principal Clinical Data Standards Consultant to join our dynamic team. Based out of Bengaluru (office-based), this role will be instrumental in enhancing clinical data standards, supporting the design and analysis of clinical trials, and contributing to breakthrough treatments in the industry.
Key Responsibilities:
Develop tools to support the implementation and compliance of CDISC, Sponsor, and ICON data standards.
Collaborate with cross-functional teams to establish effective data collection strategies and clinical data standards.
Create and maintain comprehensive training and reference materials on topics such as CDASH, SDTM, Terminology, ADaM, define-XML, and regulatory submission requirements.
Manage the creation and upkeep of data management processes and tools.
Stay updated with evolving industry trends and regulatory requirements, integrating them into ICON’s standard practices.
Your Profile:
Bachelor’s degree in Life Sciences, Computer Science, or a related field; advanced degrees preferred.
Strong experience in clinical data management and standards within the pharmaceutical or biotechnology sectors.
Advanced expertise in CDISC standards and knowledge of regulatory frameworks (e.g., FDA, EMA).
Proven analytical and problem-solving skills with excellent attention to detail.
Effective communication and collaboration skills with experience in cross-functional team environments.
What ICON Offers:
Competitive salary with performance-based rewards.
Various annual leave entitlements.
Flexible health insurance plans for you and your family.
Retirement planning benefits to secure your financial future.
Global Employee Assistance Programme (LifeWorks) available 24/7.
Life assurance and country-specific perks such as:
Childcare vouchers
Bike purchase schemes
Discounted gym memberships
Health assessments
Subsidized travel passes
Our Commitment to Inclusion:
ICON is an equal opportunity employer. We are committed to fostering a workplace that celebrates diversity, inclusion, and accessibility. We welcome applicants from all backgrounds and provide accommodations for individuals with disabilities.
If you’re passionate about shaping the future of clinical development but unsure if you meet every qualification, we encourage you to apply — you might be exactly who we're looking for.
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