Data Standards Manager III

Responsibilities • 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. Requirements: • 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.