Position Overview
The Clinical Study Report (CSR) Document Specialists is responsible to populate, track, QC and perform technical editorial checks of the CSR appendices for assigned studies, from authoring until document finalization in the DMS in compliance with current Novartis processes, ICH-GCP, and relevant regulatory requirements.
CSR Document specialists responsibilities include, but are not limited to:
Lead the CSR appendices kick off meeting and define the timelines together with the CSR sub team Plan and prioritize the appendices for publishing activities Coordinate with the TMF manager/Study Lead as applicable, to ensure completion/availability of all essential documents for the CSR appendices are in the TMF Manage the CSR appendix related activities: create and populate CSR appendix based on templates in the DMS including support for the publishing of appendicesCoordinate and track the line functions review of the draft CSR a...