Clinical Data Standards Consultant

ICON Clinical Research Ltd; Dublin; On-site; EUR 80,000 - 120,000; Full time

Benefits offered by this job

Competitive base salary

Performance related incentives

Health and wellbeing programmes

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programmes

Learning and development opportunities

Work From Home option

Job summary

ICON Clinical Research Ltd is seeking a Clinical Data Standards Consultant to support operational staff in ADaM usage and data capture for statistical analysis. The role focuses on developing tools to improve the efficiency, timeliness, and quality of data collection, tabulation, analysis, and reporting.

The candidate will participate in training development and metric collection, with opportunities to mentor staff and contribute to sponsor standard initiatives.

Qualifications

• Experience with clinical data standards; biometrics background preferred.
• CDASH/SDTM expertise and terminology knowledge.
• Strong communication and leadership abilities.

Responsibilities

• Serve on Sponsor Standards and Technology Leadership teams.
• Consult on sponsor-specific CDISC-centric implementation projects.
• Participate in industry groups focused on CDISC/PhUSE initiatives.
• Author, maintain and report status for Standards Related Project Plans.
• Lead implementation and configuration of metadata repositories for CDISC metadata.
• Mentor Clinical Data Standards Consultants.
• Lead Subject Matter Expert teams on standards topics.
• Identify areas for process improvements in data collection through reporting.

Skills

CDISC standards

CDASH

SDTM

Leadership

Communication

Education

Undergraduate degree

Tools

Metadata repository

Job description

Clinical Data Standards Consultant - ADaM 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.

Job Advert Posting A Clinical Data Standards Consultant is responsible for supporting the operational staff in the use of ADaM and the 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

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.

Benefits: Work From Home TPBN1_IJ