Project Quality and Risk Management Specialist

1 week ago

North Ryde, New South Wales, Australia Parexel Full time
Job Title: Project Quality and Risk Manager

About the Role:

We are seeking a highly skilled Project Quality and Risk Manager to join our team at Parexel. As a key member of our quality management team, you will be responsible for ensuring the highest standards of quality and risk management in our clinical trials.

Key Responsibilities:

  • Lead and facilitate the risk management process for assigned projects, identifying and mitigating potential risks and issues.
  • Collaborate with operational delivery teams to achieve and maintain an inspection-ready state, including story board oversight and quality documentation.
  • Provide expert quality advice and support to project teams, clients, and stakeholders, ensuring compliance with regulatory requirements and Parexel processes.
  • Develop and maintain quality agreements with clients, ensuring clear expectations and communication.
  • Identify areas for continuous improvement of the Quality Management System, submitting feedback on processes and participating in process improvement initiatives.

Requirements:

  • At least 8 years' experience in clinical research, including CRA experience from CRO/Pharma, with local experience in Australia.
  • Clinical Operations Lead/Leader with QI/Audit/Inspection management experience or equivalent role/responsibilities.
  • Demonstrated experience in Quality or Risk Management activities, including root cause methodologies and CAPA development.
  • Expertise in Clinical Trial Risk Management and ICH-GCP principles.
  • English proficiency (written and oral).

Education:

  • Bachelor's Degree or other relevant experience required. Life-science or other health-related discipline preferred.
  • Master's Degree in a science, technology, or industry-related discipline preferred.

About Parexel:

Parexel is a leading global biopharmaceutical services company, providing a comprehensive range of solutions to help clients accelerate the development and delivery of new and innovative treatments.

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