CSR Document Specialist, cFSP

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 appendices
• Coordinate and track the line functions review of the draft CSR appendices
• Perform QC as per QC CSR checklist and technical editorial checks of the appendices before submitting the documents in the workflow in the DMS
• Manage the finalization of the components in the DMS and inform the CSR sub team once final
• Identify and implement the improvements of processes to enhance quality of the TMF documents for relevant CSR appendices.
• Identify and communicate the risks/trends/patterns related to CSR appendix documents and work with key stakeholders to define and implement appropriate remediations.
• Development of the Financial Disclosure(FD) and BIMO module for submission studies as required

Requirements

• Bachelors degree in life-sciences/healthcare/pharmacy/information management and relevant industry experience.
• English fluency (written oral) required.
• A minimum of 1to 2 years of experience with eTMF.
• Experience working with various Document Management systems is preferred
• Knowledge of ICH GCP and other regulatory guidance as applicable to management of clinical documentation
• Experience of authoring compilation and formatting of CSR appendices according to ICH E3 is preferred
• Computer literate with experience in Microsoft Office suite.
• Ability to communicate effectively across line functions
• Able to work independently
• Ability to work in an extremely fast-paced environment with changing priorities.
• Ability to work collaboratively and cross-functionally.
• Attention to detail and accuracy in work.

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