- Leads compliance with applicable Corporate and Divisional policies and procedures.
- 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.
- 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.
- Demonstrate extensive understanding of SDTM, Standard Terminology and common coding dictionaries. Reviews SDTM conformance mapping specifications and corrects flaws proactively.
- 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)
- 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.
- Assist in the development of data standards policies, procedures and practices.
- 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.
- Be compliant with training requirements. Effectively mentor peers, Sr Data Standards Analysts and Data Standards Analysts with regard to data standards and functional operations. Train new Data Standards Analysts on process and systems related to the management and implementation of data standards.
- 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.
- MS with 8 years of relevant clinical research experience or BS with 10 years of relevant clinical research experience
- 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.
- 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.