Clinical Operations Quality Assurance Manager

1 month ago


Johannesburg, Gauteng, South Africa Kontak Recruitment Full time

We are seeking a highly skilled Quality Manager with expertise in clinical research operations to uphold and enhance the quality of our client's clinical trials. The ideal candidate will have a background as a Clinical Research Associate (CRA) with experience in pharmaceutical companies or Contract Research Organizations (CROs). This role will involve working closely with clinical operations and regulatory teams to ensure compliance with Good Clinical Practice (GCP) and relevant industry standards.

This is a remote-based position with occasional travel to clinical trial sites and partner locations. The successful candidate will be responsible for implementing and managing the quality management system (QMS) within clinical operations, ensuring adherence to GCP, Standard Operating Procedures (SOPs), and regulatory requirements.

  • Oversee data quality from clinical trials, ensuring accuracy and consistency.
  • Conduct quality control audits of trial sites, identifying gaps and recommending corrective actions.
  • Ensure compliance with local and international regulatory standards (ICH-GCP, FDA).
  • Collaborate with regulatory bodies, ensuring proper documentation of clinical research activities.
  • Provide guidance on quality and compliance issues to research teams and senior management.

We specialize in specific niche fields and are looking for a candidate with a strong background in clinical research and quality assurance. If you are a motivated and detail-oriented individual with excellent communication and analytical skills, we encourage you to apply for this exciting opportunity.



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