Risk Management Expert

2 days ago

Brisbane, Queensland, Australia beBeeQuality Full time $94,738 - $103,563

Job Title: Quality and Risk Management Specialist

Our team is seeking a highly skilled and experienced Quality and Risk Management Specialist to join our Clinical Trials Centre. The successful candidate will play a key role in ensuring the delivery of high-quality clinical trials across our network.

The primary responsibility of this role is to provide expert advice and support on quality and risk management activities, ensuring compliance with relevant regulations and standards. This includes:

  • Driving the implementation and improvement of our Clinical Trials network's Quality and Risk Management Plan;
  • Leading site-specific internal auditing functions and external audit/inspection support;
  • Contributing to the enhancement and ongoing development of our electronic Quality Management System;
  • Assisting the Quality and Risk Manager in promoting a collaborative culture focused on continuous improvement and quality excellence.

To be successful in this role, you will require:

Key Requirements:

  • A degree qualification in Health Science/Bio-Medicine or a related field, combined with relevant experience or an equivalent combination of education/training;
  • A minimum of 5 years' experience in a clinical research or clinical operations background, with at least 3 years' experience in a clinical research associate/clinical trial monitor role;
  • Phase I monitoring experience/exposure is preferred;
  • Exposure to internal/external audits is an advantage;
  • Detailed knowledge of ICH GCP and national regulations.

In addition to your technical expertise, you will also possess excellent communication and interpersonal skills, with the ability to work autonomously and as part of a multi-disciplinary team.

Benefits:

  • We offer a dynamic and inclusive work environment that values diversity and promotes opportunities for growth and development;
  • A competitive salary package, including up to 17% employer superannuation;
  • A range of employee benefits, including flexible working arrangements and access to professional development programs.

About Us:

We are a world-class Clinical Trials business unit that builds regional clinical research capacity and delivers innovative research in consultation with key stakeholders. Our goal is to improve health outcomes through the conduct of high-quality clinical trials, and we rely on talented individuals like you to help us achieve this vision.

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