Principal Clinical Data Standards Consultant in Bangalore, भारत
ICON
Bangalore, भारत
Principal Clinical Data Standards Consultant at ICON, a global clinical research organization. Design and analyze clinical trials, lead data standards implementation across teams, and ensure compliance with CDISC and regulatory requirements. Based in Bangalore, India.
Responsibilities
Coordinate consulting and advisory services delivery across teams and resolve issues
Develop tools for implementation and compliance of CDISC, sponsor, and ICON standards
Define data collection strategies and standards in collaboration with cross-functional teams
Develop and maintain training materials on CDASH, SDTM, ADaM, define-XML, and regulatory submission requirements
Monitor industry trends and regulatory updates to integrate evolving standards into organizational practices
Requirements
Bachelor's degree in life sciences, computer science, or related discipline
SDTM expert with SAS, R, and other programming language proficiency
Minimum 8 years industry experience in clinical data management and standards
Advanced proficiency in CDISC standards and FDA/EMA regulations
Statistical programming background focused on SDTM tasks
Demonstrated leadership skills and cross-functional collaboration ability
Willingness to travel approximately 15% as required
Compensation: Competitive base salary and performance-related incentives
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