Clinical Quality Manager

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Clinical Quality Manager

职位编号Job Code: CNCD09
职位 Position: Clinical Quality Manager
部门 Department:Clinical Development
汇报关系 Reports to: Vice President, Clinical Development Asia
办公地点 Location: Flexible

职位目标 Purpose or Objective of Position:

The Clinical Quality Manager is administratively and operationally responsible for the Good Clinical Practice (GCP) portion of the company’s Quality Management System (QMS), including processes and compliance, oversight of investigational sites participating in clinical studies through co-monitoring, according to the company’s Standard Operating Procedures.

主要职责 Key Responsibilities

  • Conduct on-site and remote quality oversight visits to assess investigational sites and CROs for Connect, monitoring performance as required and supports the maintenance of investigator site relationships.
  • Oversight of the (e)TMF during the study and the quality of the documents, including investigator site files.
  • Provide assessment of the completeness and accuracy of stie monitoring activities undertaken by the CRO or Connect personnel.
  • Escalate and support corrective actions as required.
  • Evaluate clinical trials sites and ensure site procedures are performed in accordance with the study procedures and protocols, applicable study manuals, GCP, and relevant regulatory requirements.
  • Support in audit and inspection readiness and site preparation in the event of a regulatory authority in partnership with QA.
  • Develop and maintain a company documentary of GCP regulations and guidelines.
  • Provide training to clinical development department employees on relevant SOPs or GCP.

职位要求Job Requirements:

Education:

  • Bachelor’s degree in Life Sciences.

 Experience:

  • At least 3 years in monitoring phase 2/3 trials with strong knowledge of clinical operations.
  • Experience with various clinical research, broad therapeutic areas is preferred.
  • Extensive knowledge of ICH-GCP and China GCP guidelines.
  • Fluent English and Chinese in both written and oral form.
  • Demonstrated problem resolution skills.
  • Proficient with office software.

直接下属Direct Reports:

Members of the Quality Management Team may report into this position.

We offer our employees the opportunity to grow individually while working collaboratively to make a difference in the lives of the patients we seek to serve.