Manager, Clinical Research

About the role

The China Development Center seeks a Manager, Clinical Research to support and conduct clinical studies aimed at reducing drug lag for Chinese patients. The role involves leading clinical programs, engaging key opinion leaders, and ensuring high‑quality data for regulatory submissions.

Key responsibilities

• Develop and execute clinical study protocols, medical monitoring plans, and data quality checks.
• Draft study reports, regulatory dossiers, and manuscript submissions.
• Collaborate with biostatisticians, regulatory affairs, operations, and other functions to design high‑quality clinical trials.
• Engage KOLs and internal stakeholders to shape clinical development plans.
• Provide scientific input for CSA, EC, HGRAC reviews and investigator meetings.
• Conduct safety/efficacy monitoring, review serious adverse events, and manage protocol deviations.

Required profile

• MD or PhD in clinical medicine with postgraduate training in Hematology.
• Deep understanding of China’s regulatory environment and clinical development procedures.
• Excellent written and verbal communication skills in English and Chinese.
• Strong team spirit, strategic thinking, and ability to prioritize multiple parallel tasks.

Required skills

• Adverse Event Reporting
• Biostatistics
• Clinical Development
• Clinical Protocol Design
• Clinical Trial Monitoring
• Data Review and Monitoring
• Good Clinical Practice (GCP)
• Medical Writing
• Pharmacovigilance
• Regulatory Document Preparation