Clinical Trials Quality Assurance Specialist

4 weken geleden

Utrecht, Utrecht, Nederland HKU Voltijd

Quality Management Professional in Clinical Research

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.

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.

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