IC

Principal Clinical Data Standards Consultant

ICON plc
Bangalore ₹3-14 LPA Posted 13 May 2025
FULL TIME
Biotechnology
Data Management
Problem Solving
Clinical Data

Job Description

  • Principal Clinical Data Standards ConsultantBengaluruOffice based
  • ICON plc is a world-leading healthcare intelligence and clinical research organization
  • Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
  • We are currently seeking a Principal Clinical Data Standards Consultant to join our diverse and dynamic team
  • As a Clinical Data Standards Consultant at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies
  • What You Will Be Doing
  • As a Senior Clinical Data Standards Consultant at ICON Plc, you will be responsible for:
  • Developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards
  • Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials
  • Developing and maintaining training and reference materials related to standards topics including CDASH, SDTM, TermiNlogy, ADaM, define-XML and regulatory submission requirements
  • Managing the development and maintenance of data management processes and tools
  • Keeping abreast of industry trends and regulatory updates related to data standards and ensuring their integration into ICON's practices
  • Your profile
  • To excel in this role, you should possess the following qualifications and attributes:
  • A Bachelor's degree in a relevant field (e g, Life Sciences, Computer Science, or related discipline); advanced degrees are a plus
  • Extensive experience in clinical data management and standards within the pharmaceutical or biotechNlogy industry
  • Advanced Proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations (e g, FDA, EMA)
  • Excellent analytical and problem-solving skills with a keen attention to detail
  • Excellent communication and collaboration abilities to work effectively in cross-functional teams
Join WhatsApp Channel