Principal Clinical Data Standards Consultant in 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