Summary:

The Clinical Quality Associate will work with Paradigm’s internal quality and clinical development teams to support oversight of Contract Research Organisations (CROs) and other outsourced partners, ensuring that clinical trial activities are conducted in accordance with applicable regulations, ICH-GCP requirements, sponsor quality standards, and contractual obligations. They will also support the teams in developing new quality processes, as needed, for conducting clinical trials.

Responsibilities:

- Provide sponsor oversight of CROs and outsourced vendors by monitoring quality and compliance performance, managing quality risks, supporting investigations, and ensuring adherence to regulatory, contractual, and sponsor requirements to maintain clinical trial data integrity.
- Manage audit findings, inspections, and CAPAs by coordinating reviews, developing and tracking corrective actions, escalating unresolved issues, and verifying the effectiveness and closure of remediation activities.
- Build and maintain strong vendor relationships by serving as a key quality contact for CROs, fostering collaboration on quality improvement initiatives, and contributing to the development of vendor oversight processes and governance frameworks.
- Support quality governance and reporting by maintaining audit and CAPA tracking systems,



preparing management reports and dashboards, identifying quality trends, and recommending process improvements to strengthen oversight and controls.

Qualifications:

- Strong regulatory and quality management expertise, with in-depth knowledge of ICH-GCP (including E6(R3)), global clinical trial regulations, sponsor oversight requirements, vendor management principles, risk management, and CAPA processes.
- Extensive clinical research and vendor oversight knowledge, including clinical trial conduct, outsourced service delivery models, and quality management systems to ensure compliance and operational excellence.
- Excellent stakeholder engagement and communication skills, with the ability to influence, collaborate, challenge constructively, and drive accountability across internal teams and external partners.
- Solid analytical, organisational, and problem-solving capabilities, demonstrating attention to detail, project management expertise, and the ability to effectively manage competing priorities in fast-paced environments.
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Biomedical Science or a related field
- 5+ years of experience within clinical research, quality assurance, clinical operations, or vendor management.

📌 Clinical Quality Associate (Melbourne)
🏢 Paradigm Biopharmaceuticals
📍 Melbourne