Data Standards Manager

Roles and Responsibilities:

• eCRF Design - Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations in eCRF design and works with the study team to correct flaws proactively.
• SDTM Conformance Mapping Create and Reviews SDTM conformance mapping specifications applying SDTM, TAUG and Client standard.
• CDISC Validation Tools - Executes validation tools (e.g., Pinnacle 21) and collaborates with other functions to resolve identified issues. Ensure any unresolved issues are appropriately documented (e.g., Clinical Study Data Reviewer's Guides).
• Create and review Trail Design domains
• Clear understanding of End-to-end traceability from Data Collection to Data reporting.
• Metadata Repository - Responsible for managing libraries of CDISC-related metadata, terminology, and related standards within the metadata repository. Provides governance oversight to Data Standards Analyst and Sr Data Standards Analyst to ensure consistency in metadata.
• Standards Development Assist in the development of data standards.
• Standards Governance Provide guidance to study team members on the appropriate use of Client's standards. Consult on complex study-specific data collection and mapping to SDTM.
• Cross-functional Team Participation Represents the Clinical Data Reporting & Standards group to ensure industry and Client standards are followed and understood.
• Communication - Clearly communicates an understanding of clinical data standards concepts, clinical principles, and regulatory guidance and acts in accordance with those principles. Effectively presents data standards concepts and logical arguments to statistical programmers, statisticians, data scientists, clinical development and regulatory study team members. Able to diplomatically and persuasively represent the interests of the Data Standards group in cross-functional initiatives.

Education & Experience:

• MS with 8 years of relevant clinical research experience (or BS with 12 years relevant experience).
• Expert level of knowledge of CDASH, SDTM, define.xml and controlled terminology.
• Experience in mapping and converting legacy data into SDTM domains for eCTD submissions. Minimum of two successful submissions of CDISC compliant data.
• Knowledge of international regulations, requirements and guidance associated with clinical data standards and the preparation of data sets for regulatory submission.
• Experience with metadata repository technology and its application in clinical data standards processes and experience with data standards governance.