About This Role
This leadership role involves taking full responsibility for the construction and optimization of the clinical trial operating system, overseeing the execution of Phase I-IV drug clinical trial projects, and ensuring project quality, progress, and compliance meet established goals. The Director will also be responsible for building and managing the clinical operations team and strategy.
Responsibilities
- Lead clinical operations team management and capability building, including the梯队培養, performance management, and cross-departmental collaboration mechanism design for core positions such as CRA
- Formulate and implement clinical operation strategies and SOP systems, promoting the standardized application and continuous improvement of electronic clinical research tools
- As the Director of Clinical Operations, deeply participate in key stages such as project initiation, protocol design, site initiation, monitoring management, data verification, and summary reports, collaborating with medical, statistical, registration, and other departments to ensure efficient project delivery
- Responsible for the selection, evaluation, and performance management of clinical trial vendors (e.g., SMO, central laboratory, logistics service providers), establishing and maintaining a high-quality external cooperation network
- Coordinate the preparation and execution of clinical operation budgets, monitor project cost-effectiveness, and regularly report operational progress, risk warnings, and improvement suggestions to management
Requirements
- Bachelor's degree or above in clinical medicine, pharmacy, biomedical engineering, public health, or a related major
- 10+ years of experience in clinical trials, with at least 5 years in a senior clinical operations management position (e.g., Senior Director of Clinical Operations, Regional Operations Head) at a multinational pharmaceutical company or innovative drug company, with successful experience in leading multiple Phase II and above registrational clinical trials
- Familiar with ICH-GCP, China's "Good Clinical Practice for Drug Clinical Trials," and relevant regulatory requirements from FDA/EMA, with solid full-process clinical trial management capabilities and audit response experience
- Excellent team leadership and cross-functional collaboration skills, capable of effectively managing a clinical operations team of over 100 people
- Proficient in core clinical operation systems and mainstream data analysis tools, with strong budget control, risk identification, and process optimization capabilities
