Associate Director - Data Standards (Hybrid)

Responsibilities

• Responsible for compliance with applicable Corporate and Divisional Polices and procedures
• 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.
• 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 Manager, Data Standards to ensure consistency in metadata.
• Policies & Procedures - Assist in the development of data standards policies, procedures and practices.

Requirements

• Bachelors of Science
• 12+ years of relevant clinical research experience (or 10+ years with a Masters)
• Expert level of knowledge of at least 3 areas of clinical data standards, and high level of knowledge in at least one additional area. (Areas include CDASH, SDTM, ADaM, define.xml, controlled terminology and metadata management.)
• 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 management of metadata to support efficient use of systems and processes
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive progra

Benefits

Additional Information

Lead, manage and develop a group of data standards experts to develop, implement and maintain end-to-end data standards from data collection to regulatory submission. Govern change control, publication and communication of new and updated data standards.

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Company Intel

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