岗位职责：

1. Leads cross-functional planning and execution of clinical studies conducted in China by translating strategy into integrated, executable study plans and ensuring disciplined delivery across the study lifecycle.

2. Provides sponsor oversight in China for feasibility, site selection, and site qualification decisions using risk-based judgment.

3. Coordinates protocol-related operational inputs and essential document reviews at China country level (e.g., protocol and amendments, ICFs.).

4. Ensures effective study delivery in China through proactive oversight of CROs and vendors, holding partners accountable for scope, quality, timelines, and cost.

5. Provides timely direction and feedback to CRO to ensure readiness of study start and execution deliverables.

6. Tracks operational performance metrics， promptly identify deviations and promote the implementation of corrective and improvement measures.

7. Ensures data integrity and operational control through effective oversight of monitoring activities, data quality, and study systems.

8. Maintains study quality and regulatory compliance through proactive, risk-based oversight aligned with DS quality standards and applicable laws and regulations.

9. Facilitates effective communication and governance by enabling structured decision-making, transparency, and alignment across internal and external stakeholders.

10. Contributes to organizational learning and capability building through knowledge sharing, process improvement, and team development.

11. Effectively manages change and complexity to maintain study control and delivery in China.

资历要求：

1. Bachelor or advanced degree in medical and health-care related field
2. Minimum of 5+years of clinical research experience in global CRO and/or pharmaceutical company. Minimum of 2+years of project management in oncology field (experienced in early phase studies will be prioritized)
3. Broad experience in clinical development and study delivery with strong knowledge of regulatory, process, and quality requirements.
4. Strong proficiency in English (written and verbal)
5. Sufficient understanding of clinical study and drug development pathways. In-depth understanding of regulations, e.g. IND/ICH GCP/ China GCP/HGRAC guidelines. 
6. Ability to assess and adapt operational plans to align with local requirements and challenges. 
7. Effective problem-solving, learning agility, and adaptability with a focus on risk identification and mitigation strategies.
8. Excellent project management soft skills, including leadership, collaboration, and communication proficiency.
9. Proficient computer skills