Clinical Trials Quality Assurance Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeQuality Full time $128,456 - $145,964
Job Overview

We are seeking a seasoned quality assurance specialist to spearhead the development and implementation of our clinical trials quality management framework.

This key role will oversee the design and execution of quality systems, conduct audits and accreditation processes, and ensure adherence to national and regulatory standards.

The ideal candidate will possess expertise in risk management concepts and processes, accreditation cycles, and demonstrated experience in clinical risk management and quality improvement processes.

Main Responsibilities:

  • Develop and implement a comprehensive quality improvement program for clinical trials
  • Foster a culture of quality, risk, and patient safety within the organization
  • Ensure compliance with ICH Good Clinical Practice (GCP) guidelines, Australian Commission on Safety and Quality in Health Care, and other relevant regulatory frameworks

Key Requirements:

  • Possession of relevant tertiary qualifications in clinical, medical science, or quality improvement fields
  • Postgraduate qualifications in research, biostatistics, or clinical trials coordination
  • Strong knowledge of risk management concepts and processes
  • Accreditation cycle experience
  • Experience in clinical risk management and quality improvement processes

Note: Applicants must hold a valid driver's license. Those without a NSW C-class license may need to obtain one within three months of appointment.

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