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Großraum Frankfurt | Permanent employment with our customer | hays-searchresults-startdate | 403120/1
Focus on the implementation and supervision of data management activities within assigned clinical trials Provide adequate sponsor oversight to data management CRO’s or external data providers (e.g. for ePRO data, laboratory data) Ensure the monitoring and supervision of the set-up and maintenance of CDMS systems, eTools like EDC and filing and archiving of trial documentation Create and execute data quality checks
Bayern | Permanent employment with our customer | hays-searchresults-startdate | 395207/1
Provide clinical data management support to the clinical trial teams (CTT) Participate in the review of the clinical trial documents (e.g. protocols, case report forms and statistical analysis) Oversee the development and implementation of clinical data management activities outsourced to the vendor in a clinical trial (i.e. Data Management Plan, eCRF, Database Specification, etc.) to ensure quality and adherence to timelines Participate in meetings with vendors to review project plans and timelines, address and resolve issues identified in the trial and requests from the CTT Coordinate the UAT of eCRF build and validation documents including but not limited to edit check document, issue logs, UAT summary report with the vendor Participate in the definition and implementation of eCRF standards Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock