Senior Manager, Data Standards

A company is looking for a Senior Manager, Data Standards (Remote). Key Responsibilities Participate in the development of data and reporting standards for clinical trials Ensure compliance with CDISC standards and oversee the creation of necessary documentation for regulatory submissions Develop training materials and communicate ongoing standard development activities across the organization Required Qualifications Experience leading the development of standards for data collection, tabulation, analysis, and reporting Experience with SDTM is required; CDASH experience is highly recommended Familiarity with ADaM and Analysis Results Metadata is helpful Active participation in CDISC teams is preferred MS with 9 years or BS with 11 years of relevant clinical research experience

Apr 25, 2025 - 01:29

A company is looking for a Senior Manager, Data Standards (Remote). Key Responsibilities Participate in the development of data and reporting standards for clinical trials Ensure compliance with CDISC standards and oversee the creation of necessary documentation for regulatory submissions Develop training materials and communicate ongoing standard development activities across the organization Required Qualifications Experience leading the development of standards for data collection, tabulation, analysis, and reporting Experience with SDTM is required; CDASH experience is highly recommended Familiarity with ADaM and Analysis Results Metadata is helpful Active participation in CDISC teams is preferred MS with 9 years or BS with 11 years of relevant clinical research experience