主要职责 Major Responsibilities and Duties:

1. Quality control (QC) activities for assigned studies:

• Develop QC plan and update the plan in accordance with study progress and risk assessment.

• Develop QC tools (e.g. QC checklists).

• Ensure the proper execution of on-site and in-house QC activities with expected timeline and satisfying quality.

• Provide recommendation to study team for Root Cause Analysis (RCA) and Corrective Actions & Preventive Actions (CAPA).

2. Collaborate with and support clinical staff to resolve quality and compliance issues, provide compliance and process advice when needed.

3. Support inspection including self-checking, inspection readiness and regulatory inspections.

4. Contribute to training activities to clinical staff and sharing/learning from inspection and QC activities.

5. Supports SOP implementation by provide review comments for new/update procedures, and provide required training relating to relevant procedures.

Education Background:

• Bachelor's degree or above of medical science or related field.

Working Experience:

• At least 6 years’ experiences in clinical research activities, experience in quality activities is required.

• Deep knowledge and understanding of clinical trial processes as well as quality management is required.

• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.

• Good knowledge of GCP as well as relevant regulations and guidelines.

Skill:

• Excellent communication and people management skills to effectively delivery tasks in a way that motivates and inspires to the organization.

• Ability to analyze, interpret, and solve complex issues.

• Ability to think strategically, objectively and with creativity and innovation.

• Excellent English on both written and verbal.

• Ability to travel nationally as required.