Clinical Data Standards Manager

Summary of the Clinical Data Standards Manager

• Acts as the functional expert in clinical data standards required by regulatory authorities and industry groups such as CDISC.
• Supports Clinical Data Managers, Data Management Leads, and the wider Clinical Trial Team to ensure clinical data is complete, accurate, consistent, and ready for regulatory submission.
• Leads and contributes to cross-functional work to develop data standard driven processes that ensure quality, consistency, and compliance.
• Serves as subject matter expert on industry standards, regulatory expectations, and the development of clinical data standards.
• Drives and participates in data standards governance activities.
• Helps improve data acquisition by streamlining and integrating data to increase efficiency and quality.
• Supports future strategies, tools, and technology related to standards, change control, and information exchange.
• Monitors industry and regulatory guidance, assesses impact, and defines implementation strategies.

In support of clinical trial activities, the CDSM will:

• Develop and maintain the internal clinical data standards library.
• Support the creation of study specific CRFs and SDTM metadata.
• Train internal teams on standards and support SDTM review and data quality checks.
• Escalate issues to the Clinical Trial Team or other relevant project teams when required.

Additional contributions:

• Lead or support initiatives focused on process improvements in data standardization.
• Participate in audits and regulatory inspections when appropriate.