Clinical Data Standards Consultant

Stellenbeschreibung:

Overview

In this role you will drive CDISC-based data standards within a global clinical operations context. You will support operational staff on ADaM and define.xml capture, build tools to improve data delivery quality, and contribute to metrics and training. You will join Sponsor Standards and Technology Leadership teams, mentor colleagues, and lead SME efforts to raise productivity and compliance. This is a chance to shape standard-driven data workflows across diverse projects and stakeholders.

Leistungen / Benefits

Competitive base salary
Health and wellbeing programmes
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes
Learning and development opportunities

Verantwortungsbereiche

Support operational staff in using ADaM and define.xml for statistical analysis within the Medidata framework
Develop tools to boost efficiency, timeliness, and quality of data collection, tabulation, analysis and reporting
Define and collect metrics on standard usage and participate in reporting to leadership
Participate in Sponsor Standards and Technology Leadership teams; consult on sponsor-specific CDISC implementations
Author, maintain, implement, and report status for Standards Related Project Plans
Configure and maintain a metadata repository for CDISC metadata, terminology, and related standards
Mentor Clinical Data Standards Consultants and lead Subject Matter Expert teams on standards topics
Identify opportunities for process improvement to enhance productivity, quality, and compliance
Analyze metrics and provide recommendations to management on process improvements

Zentrale Anforderungen

Minimum 5 years of industry experience with knowledge of clinical data standards used by biometrics
Undergraduate degree or international equivalent
Expertise in CDASH, SDTM, and associated controlled terminology; understanding of CRF design concepts
Excellent communication skills and demonstrated leadership ability