岗位职责:
1. Inspection Readiness & Regulatory Support
• Support NMPA, CFDI, and other regulatory inspections, including:
•Partner with Biogen CCL to develop CFDI inspection plan and inspection readiness activities
•Contribute to GCP inspections and ensure smooth organization of the front office and back office
•Provide responses and address questions and observations during inspection
•Follow-up implementation of CAPAs and ensure timely completion
2. Co-MV Planning and Execution
• Develop and maintain China Co-MV plans aligned with global quality strategies.
• Define Co-MV scope, frequency, and prioritization based on protocol risk, site performance, and study phase.
• Track and trend Co-MV findings to identify systemic risks and recurring issues.
3. Clinical Trial Quality Oversight
• Lead risk-based QC activities for China clinical trials.
• Perform QC reviews of critical trial documents, including but not limited to:
• Investigator Site Files (ISF)
• Trial Master File (TMF)
• Informed Consent Forms (ICF)
• Monitoring reports and follow-up letters
• Safety reporting documentation
• Ensure data integrity and patient safety are consistently protected throughout trial execution.
• Development, implementation, and verification of CAPAs
4. Drive continuous improvement initiatives to enhance trial execution quality in China.
任职要求:
• Preferable 8 years of experience in clinical research, with:
• Solid background in Clinical Operations, QA, or QC
• Direct experience supporting China regulatory inspections
• Strong understanding of:
• ICH-GCP
• NMPA/CFDI regulations
• China clinical trial operational practices