Clinical Data Standards Consultant

ICON Strategic Solutions; Frankfurt; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Job summary

ICON Strategic Solutions is seeking a Clinical Data Standards Consultant in Frankfurt, Germany. This role focuses on supporting operational staff with ADaM, developing tools for data analysis, and defining metrics for standards use.

Applicants should have at least 5 years of relevant experience, strong expertise in CDASH and SDTM standards, and excellent communication skills. The position offers competitive salary and comprehensive benefits, promoting well-being and work-life balance.

Qualifications

• Minimum of 5 years of experience in a role demonstrating knowledge of clinical data standards.
• Undergraduate degree from an accredited institution.
• Expertise in CDASH, SDTM standards, and CRF design concepts.

Responsibilities

• Consult with clients on CDISC centric implementation projects.
• Author and maintain standards-related project plans.
• Mentor Clinical Data Standards Consultants.

Skills

Knowledge of clinical data standards

Communication skills

Leadership ability

Expertise in CDASH and SDTM

Education

Undergraduate degree or international equivalent

Job description

Clinical Data Standards Consultant - ADaM

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.

What ICON Can Offer You

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well‑being.
• Life assurance
• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.