ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
A Clinical Data Standards Consultant is responsible for supporting the operational staff in the use of ADaM and the define.xml capture for statistical analysis within the Medidata standard. They will develop tools to increase the efficiency, timeliness and quality of deliverables for data collection, tabulation, analysis and reporting. They will also define and collect metrics about the use of standards. They will participate in the development of training of the operational staff in the areas of their expertise.
What You Will Do:
Serve on Sponsor Standards and Technology Leadership teams.
Consult with clients on sponsor-specific CDISC centric implementation projects.
Participate in industry groups focused on the development of standards related initiatives (e.g. CDISC, PhUSE etc.).
Author, maintain, implement, and report status for Standards Related Project Plans.
Responsible for the implementation, strategy, and configuration of a metadata repository used to manage libraries of CDISC related metadata, terminology and related standards.
Mentor Clinical Data Standards Consultants. * Lead Subject Matter Expert teams on topics relevant to standards.
Identify areas for process improvement which may increase productivity, quality and / or compliance of deliverables in the areas from data collections through analysis and reporting.
Participate in the analysis of metrics and in creating recommendations to the management teams on process improvements together with the Director of Global Data Standards.
Your Profile:
• Minimum of 5 years of experience in industry in a role demonstrating knowledge of clinical data standards used by biometrics.
• An undergraduate degree or international equivalent from an accredited institution
• Demonstrated expertise in CDASH, SDTM standards and associated controlled terminology with a good understanding of CRF design concepts.
• Excellent communication skills with demonstrated leadership ability.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including 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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
Skills Required
- Minimum of 5 years industry experience demonstrating knowledge of clinical data standards used by biometrics
- Undergraduate degree or international equivalent from an accredited institution
- Demonstrated expertise in CDASH, SDTM standards and associated controlled terminology with good understanding of CRF design concepts
- Experience supporting ADaM and define.xml capture for statistical analysis within the Medidata standard
- Experience implementing, configuring, and managing a metadata repository for CDISC-related metadata and terminology
- Ability to develop tools to increase efficiency, timeliness and quality of data collection, tabulation, analysis and reporting
- Excellent communication skills with demonstrated leadership ability and experience mentoring or leading SME teams
- Participation or engagement with industry standards groups (e.g., CDISC, PhUSE)
ICON plc Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.
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Healthcare Strength — Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
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Leave & Time Off Breadth — Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
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Retirement Support — Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.
ICON plc Insights
What We Do
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
