Data Standards Manager III

• Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides as well as FDA guidance and regulation regarding electronic submission of data.
• Keeps abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing.
• eCRF Design - Demonstrates extensive understanding of CDASH and SDTM standards and concepts.
• Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards.
• Recognizes limitations if eCRF design and correct flaws proactively.
• SDTM Conformance Mapping - Demonstrate extensive understanding of SDTM, Standard Terminology and common coding dictionaries.
• Reviews SDTM conformance mapping specifications and corrects flaws proactively.
• CDISC Validation Tools - Demonstrates knowledge of rules for SDTM and the associated define.xml file or rules for ADaM and the associated define.xml file and able to appropriately interpret results from common validation tools.
• Executes validation tools and collaborates with other functions to resolve identified issues.
• Ensure any unresolved issues are appropriately documented (for example in the FDA?s Data Reviewer?s Guides).
• 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.
• Policies & Procedures - Assist in the development of data standards policies, procedures and practices.
• 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.
• Able to diplomatically and persuasively represent the interests of the Data Standards group in cross-functional initiatives.
• Training & Mentoring - Effectively mentoring peers on the Data Standards team regarding data standards and functional operations.
• Train new Data Standards Analysts on process and systems related to the management and implementation of data standards.
• CDISC involvement - Maintains external reputation of a clinical data standards expert.
• Ensures consolidated review comments from Data Standards group and Statistical Programming are provided for applicable CDISC standards released for public review.
• Submits at least one abstract per year for presentation at a CDISC Interchange.

• Expert level of knowledge of at least three areas of clinical data standards, and high level of knowledge in at least one additional area.
• Areas include CDASH, SDTM, ADaM, define.xml and controlled terminology. SDTM expertise is required.
• Familiarity with other clinical data standards including BRIDG, ODM and SHARE.
• 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.
• Experience in supporting the development of standard procedures, guidelines and templates.

Katalyst HealthCares & Life Sciences