• Full-time, fixed term until 16 April 2026
• Dynamic opportunity to work within the NHMRC Clinical Trials Centre at the University of Sydney as a Trial Integrity and Quality Manager
• Base Salary $140,913 - $148,684 + 17% superannuation

About the opportunity

The NHMRC Clinical Trials Centre (CTC) is a flagship centre of excellence in clinical trials and related research at the University of Sydney. We design and deliver trials and related research, including coordination, monitoring, data acquisition and management, and statistical analysis. Our health economics, biostatistics, systematic reviews, and biomarker teams work with trial data and inform healthcare providers about best practice.

The Trial Integrity and Quality Manager plays a pivotal leadership role within the CTC, overseeing the quality and regulatory compliance of clinical trials to ensure alignment with international best practices and Good Clinical Practice (GCP) standards. As a subject matter expert, the Manager provides strategic guidance on quality frameworks, drives continuous improvement, and leads initiatives that uphold trial integrity across diverse, high-impact research projects. Working under broad direction, the role exercises a high degree of autonomy and professional judgement, liaising with senior stakeholders and contributing to strategic planning, audit readiness, and workforce capability across the Centre and the Faculty of Medicine and Health.

Your key responsibilities will be to:

• Provide strategic and expert advice on clinical trial quality assurance, ensuring compliance with international, national and University regulations, including ICH GCP and TGA requirements.
• Lead the design and implementation of quality frameworks, tools and SOPs that support risk-based, fit-for-purpose approaches to clinical trial oversight and continuous improvement.
• Oversee internal audits and coordinate external audit processes, serving as the key contact for auditors and driving quality improvements across the Centre.
• Develop and deliver training programs and quality initiatives that empower clinical trials staff and ensure high standards of regulatory compliance.
• Partner with senior leaders and stakeholders across the NHMRC Clinical Trials Centre and the Faculty of Medicine and Health to embed a culture of quality and operational integrity.
• Build and maintain effective relationships with internal teams and external partners to support seamless integration of compliance and quality practices across clinical research projects.

About you

• Postgraduate qualifications in a relevant field
• Extensive experience in clinical trial quality assurance, with strong knowledge of ICH GCP, regulatory frameworks (e.g. TGA, FDA), and the full clinical trial lifecycle from start-up through to close-out.
• Proven ability to design and implement quality frameworks, audit strategies, and CAPA processes in a complex clinical research or academic environment, ensuring compliance while supporting innovation.
• Demonstrated leadership and people management experience, including staff supervision, training, performance management, and resolving a diverse range of HR or operational issues.
• Strong interpersonal and communication skills, with the ability to influence, negotiate, and guide colleagues in a collaborative and respectful manner, especially when managing sensitive compliance issues.
• Excellent organisational and project management skills, with the ability to juggle competing priorities, meet deadlines, and maintain a strong attention to detail in a high-volume environment.
• High-level computing and data analysis skills, including familiarity with clinical trial platforms (e.g. Oracle, Medidata, InForm) and proficiency in the Microsoft Office suite, with the ability to develop and interpret quality data and reports.

Sponsorship / work rights for Australia

Work Rights: you must have unrestricted work rights in Australia for the duration of this employment to apply. Visa sponsorship is not available for this appointment.

Pre-employment checks

Your employment is conditional upon the completion of all role required pre-employment or background checks in terms satisfactory to the University. Similarly, your ongoing employment is conditional upon the satisfactory maintenance of all relevant clearances and background check requirements. If you do not meet these conditions, the University may take any necessary step, including the termination of your employment.

EEO statement

At the University of Sydney, our shared values are trust, accountability and excellence and we strive to be a place where everyone can thrive. We are committed to creating a University community that thrives through diversity and reflects the wider community that we serve. We deliver on this through our commitment to diversity and inclusion, evidenced by our people and culture programs, as well as key strategies to increase participation and support the careers of Aboriginal and Torres Strait Islander People, women, people living with a disability, people from culturally and linguistically diverse backgrounds, and those who identify as LGBTIQ+. We welcome applications from candidates from all backgrounds.

We are proud to be recognised as an Australian Workplace Equality Index (AWEI) Gold employer. Find out more about our work on diversity and inclusion.

How to apply

Applications (including a cover letter, CV, and any additional supporting documentation) can be submitted via the Apply button at the top of the page.

For employees of the University or contingent workers, please login into your Workday account and navigate to the Career icon on your Dashboard. Click on USYD Find Jobs and apply.

For a confidential discussion about the role, or if you require reasonable adjustment or any documents in alternate formats, please contact Roshik Prasad, Recruitment Operations by email to roshik.prasad@sydney.edu.au

Copyright The University of Sydney

The University reserves the right not to proceed with any appointment.

Click to view the Position Description for this role.

Applications Close

Wednesday 02 July 2025 11:59 PM