About the Role
The Trial Integrity and Quality Manager plays a pivotal leadership role, overseeing the quality and regulatory compliance of clinical trials. This position requires expertise in clinical trial quality assurance, including knowledge of international, national, and university regulations.
Key Responsibilities
* Provide strategic advice on clinical trial quality assurance, ensuring compliance with relevant regulations.
* Lead the design and implementation of quality frameworks, tools, and SOPs that support risk-based approaches to clinical trial oversight.
* Oversee internal audits and coordinate external audit processes.
* Develop and deliver training programs to empower clinical trials staff.
* Partner with senior leaders to embed a culture of quality and operational integrity.
Required Skills and Qualifications
* Postgraduate qualifications in a relevant field.
* Extensive experience in clinical trial quality assurance, with strong knowledge of ICH GCP and regulatory frameworks.
* Demonstrated leadership and people management experience.
* Strong interpersonal and communication skills.
* Excellent organisational and project management skills.
* High-level computing and data analysis skills.
Benefits
This is an opportunity to work within the NHMRC Clinical Trials Centre at the University of Sydney. The position offers a dynamic environment with diverse, high-impact research projects.
Others
Your key responsibilities will be to:
1. Provide strategic and expert advice on clinical trial quality assurance.
2. Lead the design and implementation of quality frameworks.
3. Oversee internal audits and coordinate external audit processes.
4. Develop and deliver training programs.
5. Partner with senior leaders.
The NHMRC Clinical Trials Centre is a flagship centre of excellence in clinical trials and related research. We design and deliver trials and related research, including coordination, monitoring, data acquisition and management, and statistical analysis.