Job Description
**Position Summary:**
The Clinical Study Report (CSR) Document Specialist is responsible for the coordination, formatting, quality control, document management, and finalization of Clinical Study Report appendices for assigned studies. This role works closely with TMF Managers, Study Leads, Medical Writers, Biostatisticians, Clinical Operations, Regulatory Affairs, Data Management, and Quality teams to ensure that clinical study documentation is accurate, compliant, submission-ready, and delivered according to project timelines.
The CSR Document Specialist plays a critical role in supporting the preparation and maintenance of clinical documents in compliance with ICH-GCP guidelines, company SOPs, regulatory requirements, and industry standards.
**Key Responsibilities:**
**Clinical Study Report Support**
+ Coordinate the development, compilation, review, and finalization of Clinical Study Report (CSR) appendices.
+ Lead the CSR appendices ...
The Clinical Study Report (CSR) Document Specialist is responsible for the coordination, formatting, quality control, document management, and finalization of Clinical Study Report appendices for assigned studies. This role works closely with TMF Managers, Study Leads, Medical Writers, Biostatisticians, Clinical Operations, Regulatory Affairs, Data Management, and Quality teams to ensure that clinical study documentation is accurate, compliant, submission-ready, and delivered according to project timelines.
The CSR Document Specialist plays a critical role in supporting the preparation and maintenance of clinical documents in compliance with ICH-GCP guidelines, company SOPs, regulatory requirements, and industry standards.
**Key Responsibilities:**
**Clinical Study Report Support**
+ Coordinate the development, compilation, review, and finalization of Clinical Study Report (CSR) appendices.
+ Lead the CSR appendices ...