Principal Clinical Data Standards Consultant
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Job Description
Principal consultant developing CDISC-compliant data standards for ICON’s global clinical research organization. Advising sponsors, governing standards, and delivering training across clinical trials.
Responsibilities:
- Provide expert-level functional knowledge in at least one standards domain and develop standards content internally and for sponsor-facing projects
- Develop, implement, and maintain ICON Data Collection standards libraries in compliance with CDISC, sponsor, and regulatory requirements
- Guide standards implementation and ensure compliance across clinical data management activities
- Recommend and drive best practices to improve processes, products, and services
- Define data collection strategies and standards for clinical trials with cross-functional teams
- Participate in standards governance activities and provide expert input on complex topics
- Lead or contribute to departmental initiatives, potentially serving as project lead and coordinating team members
- Support development of training materials and reference documentation on CDASH and Controlled Terminology
- Monitor industry trends, regulatory changes, and emerging standards
- Mentor and guide junior team members
- Develop and implement end-to-end data standards libraries from data collection to analysis
- Provide internal and external consulting on CDISC standards compliance and implementation
- Support sponsors with development, implementation, maintenance, and governance of data standards content
- Develop and deliver training for internal teams and external sponsors
- Support development and maintenance of technologies used to implement data standards
- Participate in standards governance team meetings and provide standards input
- Lead others in solving complex problems and identify innovative solutions
- Present and defend analyses and secure approval on complex matters
- Travel approximately 15% domestically and/or internationally
Requirements:
- Expert functional knowledge in at least one standards area
- Ability to apply expert knowledge of business challenges and recommend best practices
- Experience developing standards content internally and for sponsors
- Ability to provide guidance on standards implementation and compliance
- 12–15 years of experience
- Equivalent combination of education, training, and relevant experience may be considered in place of the stated education and experience
- Ability to lead others in solving complex problems using sophisticated analytical thought
- Ability to exercise judgment and identify innovative solutions
- Ability to significantly impact operational, project, or departmental objectives
- Ability to ensure quality standards are achieved
- Ability to work guided by business strategy
- Ability to adapt communication style and use persuasion
- Ability to present and defend analysis and secure approval on complex matters
- Willingness to travel approximately 15% domestically and/or internationally
- Legal right to work in the country where the role is based
Benefits:
- Continuous learning culture and professional development opportunities
- Comprehensive and competitive total reward package
- Excellent base pay
- Variable pay and recognition programs
- Medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
- Supportive policies and wellbeing initiatives
- Reasonable accommodations during the recruitment process
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