Clinical Trials Program Lead

The University of Sydney; St Leonards; On-site; AUD 137,000 - 167,000; Full time

Job summary

The Kolling Institute, part of The University of Sydney, is seeking a Clinical Trials Program Lead to oversee the Osteoarthritis Clinical Research Group’s trials. This role provides operational leadership, ensures protocol and regulatory compliance, and delivers robust trial governance and performance across a diverse research team.

Based at the Kolling Institute in St Leonards, you will lead trial staff, coordinate with Chief Investigators and sponsors, and manage budgets and reporting to

Qualifications

• Experience developing and working on research projects with protocols and ethics submissions.
• Financial literacy with budgeting and income/ expenditure control.
• Clinical trial coordination experience across multiple stakeholders and regulatory processes.
• Excellent communication, negotiation and discretion in operational matters.
• Strong time management with ability to prioritise and meet deadlines.

Responsibilities

• Lead the clinical trial operations and oversee timely delivery of the group’s trials, including establishment, implementation, evaluation, prioritisation and reporting.
• Ensure compliance with study protocols, ethics, GCP, policies and regulatory requirements.
• Develop and manage budgets for all clinical trials, including financial governance and reporting.
• Establish and maintain relationships with Chief Investigators, sponsors, funding bodies and trial staff.
• Provide leadership and direction to clinical trial team members and oversee their performance and development.

Skills

Research project management

Clinical trials coordination

Budget management

Regulatory compliance

Stakeholder engagement

Job description

The University of Sydney – St Leonards NSW

• Full-time, fixed-term opportunity until 31 December 2027
• Utilise your exceptional Clinical Trials experience to lead and manage clinical trials in the Osteoarthritis Clinical Research Group
• Base Salary $152,045 + 17% superannuation
• Located at The Kolling Institute, St Leonards

About the opportunity

The Kolling Institute is the longest-running research organisation in NSW, bringing together a large, talented team driven by a common goal to help diagnose, prevent and treat disease, and improve the care our community receives. The Kolling Institute is part of the University of Sydney’s Faculty of Medicine and Health, located in the Northern Sydney (Arabanoo) Precinct.

The Clinical Trials Program Lead is responsible for the overall management of the clinical trials in the research group and provides operational leadership, guidance, and support to members of the research group’s clinical trials team. They direct the activities of clinical trial staff engaged in clinical research projects to ensure compliance with protocols and overall research objectives. The Clinical Trials Program Lead provides high-level clinical trial knowledge and expertise to the Chief Investigator and the research team to support the clinical trial requirements for the work area.

Your key responsibilities will be to:

• Lead the clinical trial operations and oversee the timely delivery of the group’s clinical trials, including overseeing the establishment, implementation, ongoing evaluation, prioritisation, and reporting of all clinical trials. This includes assuming project manager responsibility for trials at times.
• Ensure compliance with study protocols, ethics, Good Clinical Practice (GCP) guidelines, institutional policies, and relevant local and international regulatory requirements.
• Develop and manage budgets for all clinical trials, including providing effective financial governance and control by conducting financial audits, identifying trends and issues, preparing, and completing financial reports, action plans and implementing change where required.
• Establish and maintain effective and productive relationships with internal and external clinical trial program stakeholders including Chief Investigators, trial sponsors, other external funding organisations and clinical trial staff.
• Provide leadership and direction to clinical trial team members and is responsible for the team’s performance and development.

About you

• Experience in developing and working on research projects, including expertise in using research protocols, experimental design, ethics submissions and grant applications.
• Financial management experience and literacy, experience managing budgets and controlling income and expenditure.
• Relevant experience in clinical trial coordination, or managing research projects encompassing multiple stakeholders including monitoring and data management, and a detailed understanding and working knowledge of Good Clinical Practice and regulatory and ethical approval processes across Australia.
• Excellent interpersonal, verbal and written communication skills with sound negotiating and conflict resolution skills and a demonstrated level of tact and discretion in dealing with day-to-day operational matters.
• Excellent time and workload management skills with demonstrated ability to prioritise effectively, manage multiple tasks, meet deadlines, and achieve required outcomes.

Sponsorship / work rights for Australia

You must have unrestricted work rights in Australia for the duration of this employment to be eligible to apply. Visa sponsorship is not available for this appointment.

Pre-employment checks and declarations

Your employment is conditional upon the successful completion of all pre-employment or background checks required for the role in terms satisfactory to the University. Also, to meet the University’s obligations under the National Higher Education Code to Prevent and Eliminate Gender-Based Violence you will be asked to declare if you have been investigated for, or found to engaged in, sexual harm or gender-based violence in the course of previous employment or in a legal process. Similar, 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.

As this position is located on a NSW Health site, it is a regulatory requirement to complete compulsory employment checks prior to starting in this position. For more information and instructions, please visit: NSW Health employment requirements (Category A).

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 LGBTQIA+. We welcome applications from candidates from all backgrounds.

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

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