Clinical QC Manager

Department
部门

Clinical Operation, Research and Development
临床运营部,研发部

Title
职位

(Associate / Sr.) Clinical Quality Control Manager
临床运营质量控制(副 / 高级)经理

Starting Date
任职时间
ASAP
Direct Report
直线经理

(Associate) Clinical Quality Control Director
临床质量控制(副)总监

Direct Subordinates
直接下属
N/A
Primary Function
主要职能

Ensure clinal operations activates adhere to external and internal regulatory requirement, e.g. ICH-GCP, China GCP, relevant Chinese regulations and SOPs in conducting clinical trials. Provides quality and compliance oversight on study/site management and promotes quality improvement.

确保临床运营部的活动符合公司内部和外部各项政策、法律和法规,如ICH-GCP、 中国GCP、中国相关法规及临床试验各项SOP的规定。为临床研究/研究中心提供质量和合规监管,促进质量提升。

Major Responsibilities and Duties
主要职责和任务
  • Developing, maintaining Clinical operation functional SOPs and forms according to ICH-GCP, China GCP, and updating or optimizing procedures and forms as needed.
  • Delivering quality related training and refreshing to clin ops team to emphasize key points and compliance.
  • Develop and update general Quality Control plan.
  • Provide advice and support to Clinical Operations, Medical Science including Project Managers and other key stakeholders about quality control, risk assessment and management, and corrective actions.
  • Conduct QC activities including selected Monitoring Visit Report review, TMF review and quality visit.
  • Support QA activities on vendor, CRO, site audits etc.
  • Provide support and advise on CTMS, eTMF setup as needed.
  • 依照ICH-GCP和中国GCP的要求撰写、维护、更新或优化临床运营部SOP及相应表格。
  • 为临床运营团队提供和更新质量相关的培训,强调关键点和依从性。
  • 制定和更新常规质量控制计划。
  • 为临床运营,医学,包括项目经理和其他关键人员提供质量控制,风险评估与管理以及纠正措施的建议和支持。
  • 实施质量控制活动,包括审阅选定的监查访视报告,TMF审阅和实施质量访视。
  • 支持QA对供应商,CRO,研究中心的稽查活动。
  • 必要时为CTMs, eTMF的建立提供支持和建议。
Qualifications
资格要求
  • Bachelor’s degree and above.
  • Major in clinical medicine, pharmacy and biology or relevant.
  • At least 5 year pharmaceutical industrial experience and 2ys as QC manager or equivalent.
  • Working experience as CRA and clinical management staff for studies preferred.
  • 1 year proven training or coaching experience.
  • Procedural documents developing or generating experience.
  • Ability to work independently and collaborate.
  • Strong oral and written communication skills in Chinese and English.
  • 大学本科及以上学历。
  • 临床医学,药学,生物学或其他相关专业。
  • 至少5年药企工作经验,其中至少2年质量控制经理或相关工作经验。
  • 具有CRA工作经验和临床研究管理经验的优先。
  • 1年培训或相应经验。
  • 流程文件撰写经验。
  • 独立工作能力和团队合作能力。
  • 优秀的中英文书面和口头表达能力。