Data Standards Manager

Roles & Responsibilities

• Critically reviews 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.
• Create and Reviews SDTM conformance mapping specifications applying SDTM, TAUG and Client standard.
• 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).
• Create and review Trail Design domains.
• Clear understanding of End-to-end traceability from Data Collection to Data reporting.
• 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.
• Aid in the development of data standards.
• 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.
• Represent the Clinical Data Reporting & Standards group to ensure industry and Client standards are followed and understood.
• Clearly communicate an understanding of clinical data standards concepts, clinical principles, and regulatory guidance and act in accordance with those principles.
• Effectively present 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.

Requirements

• 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.