Clinical Data Standards Consultant
ICR United States USA
Apply to this jobICON 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
Summary
Support use of ADaM and define.xml, develop tools, and mentor staff in clinical data standards.
Job title
Clinical Data Standards Consultant
Experience level
5+ years
Minimum experience
5+ years exp
Industry
healthcare
Location requirements
Germany, Spain, Hungary, UK, Bulgaria, Romania, Portugal, Poland, South Africa, Ireland; remote allowed
Salary
Not specified
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Unknown location