Quality Management Specialist

Quality Management Specialist (at the rank/grade of Technical Officer/Research Assistant I/II) in the Clinical Trials Centre (Ref: 526171)

The Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine (HKUMed) and dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices and medical technologies. HKU-CTC offers long-term development opportunities to passionate talents who pursue career advancement and success. 

Quality and compliance are the key to the success of clinical research projects. HKU-CTC’s Quality Management Team (QMAT) is a professional team dedicated to ensuring research quality and compliance through formulation and implementation of multi-dimensional quality assurance (QA) and quality control (QC) measures. QMAT is seeking talents who are interested/experienced in practising the quality management profession in the clinical research domain.

Main Responsibilities

• Perform quality management for HKU-CTC and the clinical study activities under HKU;
• Maintain a robust QA system;
• Develop and maintain standard operating procedures;
• Facilitate the participation in quality assurance and accreditation schemes; and
• Perform internal QC and coordinate external audits/inspections.

Requirements

• Bachelor’s degree or above in Biological, Medical, Life Sciences, Quality Management or related disciplines;
• Minimum of 2 years’ experience in clinical research quality management, monitoring and/or project management/operations;
• Good knowledge in Good Clinical Practice (GCP) and local/national/international regulations and guidelines related to clinical research is necessary;
• Strong coordination and problem-solving skills, good interpersonal and communication skills, and commitment to quality and compliance;
• Detail-minded, able to handle multiple concurrent tasks, self-motivated and have a strong sense of responsibility;
• Good command of written and spoken English and Chinese is a must; and
• Proficiency in Putonghua is a plus.

The appointment will be made on a two-year fixed-term full-time contract, and commence as soon as possible with the possibility of renewal subject to satisfactory performance. A highly competitive salary commensurate with qualifications and experience will be offered, together with contract-end gratuity and University contribution to a retirement benefits scheme at 10% of basic salary. Other benefits include annual leave and medical benefits.

The University only accepts online applications for the above post. Applicants should apply online at the University's career site (https://jobs.hku.hk) and upload an up-to-date C.V. Review of applications will start from April 8, 2024 and continue until April 24, 2024 or until the post is filled, whichever is earlier.

The information provided will be treated in strict confidence and be used only for consideration of your application for relevant / similar posts within the Group/ Company.