Job Title: Principal Clinical Data Standards Consultant
Location: Bangalore, Chennai, Bengaluru (Hybrid: Office/Remote)
About ICON plc: ICON plc is a world-leading healthcare intelligence and clinical research organization. We are proud to foster an inclusive environment that drives innovation and excellence as we shape the future of clinical development.
Responsibilities:
Develop tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards.
Collaborate with cross-functional teams to define data collection strategies and standards for clinical trials.
Develop and maintain training and reference materials related to standards topics including CDASH, SDTM, Terminology, ADaM, define-XML, and regulatory submission requirements.
Manage the development and maintenance of data management processes and tools.
Monitor industry trends and regulatory updates related to data standards and ensure their integration into ICON’s practices.
Qualifications:
Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science, or a related discipline); advanced degrees are a plus.
Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry.
Advanced proficiency in CDISC standards and familiarity with relevant regulations (e.g., FDA, EMA).
Strong analytical and problem-solving skills with a high attention to detail.
Excellent communication and collaboration abilities for effective cross-functional teamwork.
Benefits of Working at ICON:
Various annual leave entitlements customized per country.
A range of health insurance options to support individual and family needs.
Competitive retirement planning offerings for future financial security.
Access to the Global Employee Assistance Programme (LifeWorks), providing 24-hour support through a global network of over 80,000 specialized professionals.
Life assurance and flexible, country-specific optional benefits, such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, and health assessments.
At ICON, inclusion and belonging are fundamental to our values. We are committed to maintaining an accessible, discrimination-free workplace where all qualified applicants receive equal consideration for employment.
If you require a reasonable accommodation for any part of the application process or to perform essential job functions, please submit a request here.
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