Clinical Data Standards Manager

il y a 2 semaines


Bruxelles, Belgique SolCur Temps plein

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.


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