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Senior Clinical Research Operations Specialist

3 weeks ago

Geelong, Victoria, Australia beBeeGcp Full time $86,500 - $144,000
Senior GCP Quality Specialist

We are seeking a seasoned professional to ensure adherence to company policies, study protocols, GxP guidelines and global regulatory requirements governing clinical research activities.

Key Responsibilities:

  • Lead comprehensive quality audits in accordance with regulations and standards governing clinical research.
  • Develop strategic audit plans to identify areas of concern and ensure regulatory compliance.
  • Provide expert consultation on GxP requirements and quality assurance strategies.
  • Author detailed audit reports based on findings.

Requirements:

  • At least 7-9 years of experience in quality auditing functions in a CRO or pharmaceutical/biotechnology organization.
  • Strong understanding of compliance and risk management issues relating to clinical research.
  • Proven leadership experience is required.