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Project Quality and Risk Manager

2 months ago

North Ryde, New South Wales, Australia Parexel Full time
Job Description

Job Summary:

The Project Quality and Risk Manager will be responsible for ensuring the quality and integrity of clinical trials, identifying and mitigating risks, and providing expert quality advice to project teams. This role will also involve collaborating with operational delivery teams to achieve and maintain an inspection-ready state.

Key Responsibilities:

  • Develop and implement quality management systems to ensure compliance with regulatory requirements and Parexel standards.
  • Identify and mitigate risks associated with clinical trials, including data integrity and regulatory compliance.
  • Provide expert quality advice to project teams, including risk management and quality control.
  • Collaborate with operational delivery teams to achieve and maintain an inspection-ready state.
  • Develop and maintain quality agreements with clients and partners.
  • Conduct quality audits and inspections to ensure compliance with regulatory requirements and Parexel standards.
  • Develop and implement corrective and preventive actions (CAPAs) to address quality issues.
  • Provide training and support to project teams on quality management and risk mitigation.
  • Participate in process improvement initiatives to enhance quality management and risk mitigation.

Requirements:

  • At least 8 years of experience in clinical research, including CRA experience from CRO/Pharma.
  • Clinical Operations Lead/Leader with QI/Audit/Inspection management experience or equivalent role/responsibilities.
  • Demonstrated experience in Quality or Risk Management activities.
  • Expertise in root cause methodologies and CAPA development.
  • Expertise in Clinical Trial Risk Management.
  • Expertise with 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.

Skills:

  • Excellent interpersonal, verbal and written communication skills.
  • Advanced analytical skills.
  • Strong ability to develop professional, collaborative relationships.
  • Excellent skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data.
  • Highly adaptable to changing environments.
  • Strong ability to plan, organize, prioritize and manage workload independently.
  • Strong quality oriented with an attention to detail.
  • Excellent ability to manage the complexity of a matrix environment.

Language: English (en-US)