Vacancy description

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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