Clinical Trial Operations Specialist

2 weeks ago

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

Job Opportunity

We are seeking a Quality and Risk Professional to join our Clinical Trials Centre. The successful candidate will have experience in clinical trial operations and phase I, with a strong understanding of applied ICH GCP to clinical trial protocols.

Key Responsibilities

The Quality and Risk Professional will be responsible for:

  • Driving the implementation and improvement of the Quality and Risk Management Plan;
  • Leading site-specific internal auditing function and external audit/inspection support;
  • Contributing significantly to enhancing the utilisation and ongoing development of the newly launched electronic Quality Management System;
  • Assisting in promoting a collaborative culture focussed on continuous improvement and Quality excellence.

Requirements

To be successful in this role, you will possess:

  • A degree qualification in Health Science/Bio-Medicine or related field and relevant experience or an equivalent combination of experience and/or education/training;
  • Minimum 5 years' experience in clinical research within the pharmaceutical/biotechnology industries at Sponsor/CRO/site level, with at least 3 years in a dedicated clinical operations role requiring working understanding/oversight of applied ICH GCP to clinical trial Protocols;
  • Phase I working/monitoring exposure (preferred);
  • Exposure to internal/external audits (advantageous); and
  • Detailed working knowledge of ICH GCP and national regulations within the Australian clinical research landscape.

Benefits

As a valued member of our team, you can expect a range of benefits including opportunities for professional growth and development.

About Us

Our organisation is committed to creating an inclusive environment where each person feels they belong and are respected, connected and empowered to contribute and grow in meaningful ways.

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