Clinical QC Manager

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REJECT COOKIES Clinical QC Manager

Responsibilities and Duties:

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.

Qualifications:

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.