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Manager of Data Standards
Job Summary
A company is looking for a Manager, Data Standards.
Key Responsibilities
- Participate in the development of data and reporting standards within assigned therapeutic areas
- Ensure consistency across standard types and develop training materials for proper use of standards
- Oversee the creation of SDTM documentation for regulatory submissions and consult on conformance issues
Required Qualifications, Training, and Education
- Experience leading development of standards for data collection, tabulation, analysis, and reporting
- Experience with SDTM is required; CDASH experience is highly recommended
- Experience with ADaM and regulatory submission documentation is helpful
- MS with 8 years or BS with 10 years of relevant clinical research experience
- Active participation in CDISC teams is preferred
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COMPLETE JOB DESCRIPTION
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