The Opportunity

An exciting opportunity is available for a Clinical Research Manager to join the Burnet Diagnostic Initiative team at Burnet!

In this role you will oversee the planning, execution, and management of clinical trials and research studies, ensuring they comply with regulatory requirements, Good Clinical Practice (GCP) and ethical standards. You will also be involved in coordinating cross-functional teams, budget reporting, and maintaining timelines to facilitate high-quality research outcomes. You will collaborate with investigators, regulatory authorities and industry partners to ensure clinical studies and trials are conducted efficiently and effectively. Being part of Commercialization and Research Translation working group, you will also provide project management support for the BDI projects, support data analyses, implement best practices, and contribute to the advancement of medical knowledge and patient care.

You will also:

• Prepare, maintain and manage clinical study/trial documentation and processes, study/trial protocols, reports, case report forms and operational documentation.
• Manage critical components of clinical operations, including study planning, clinical supply logistics, data/sample/document management, and quality assurance.
• Initiate, complete or coordinate completion, maintain and manage the essential documents and the Investigator Site File.
• Train research staff, ensuring continuous education and adherence to best practices.
• Conduct data quality monitoring, site audits, and coordinate safety monitoring, including adverse event reporting and management.
• Complete project management activities, including defining project scope, goals, deliverables and timelines, lead cross-functional teams to ensure project milestones and objectives are met, manage documentation, reporting, and compliance with industry standards.
• Ensure all work and processes meet ISO 9001 quality management system and certification requirements.
• Provide verbal and written reports to management and other internal and external stakeholders in meetings and via project/task management software when required.
• Travel to attend relevant work specific events (e.g. seminars, meetings or courses) to keep abreast of developments in the areas of work.

Refer to the attached position description for full details. This is a Full Time, 2-year fixed term position. You will have flexible working hours as well as up to 2 days per week working from home option.

https://www.burnet.edu.au/Position Description_Clinical Research Manager

Let's talk about you

The following criteria are essential requirements:

• Bachelor of Science/Biomedical Science degree in a biological or clinical laboratory discipline.
• A minimum of three years' experience in clinical research and clinical study/trial management at a senior level.
• Strong knowledge of the ICH-GCP standard and requirements.
• Excellent leadership, organizational, and problem-solving skills.
• Ability to manage multiple projects and work collaboratively with diverse and multi-functional teams.
• Proficiency in data management tools, clinical study/trial software and databases.
• Experience in project management, including in the use of project management tools (e.g. MS Project).

The following are preferable but not essential:

• Experience with clinical studies for in-vitro diagnostic assays.
• Knowledge of clinical study/trial regulatory guidelines and requirements (e.g. TGA, FDA, EMA) and other relevant standards (e.g. ISO 20916).

The Burnet experience?

We want you to have a successful and meaningful career at Burnet and are committed to providing a supportive workplace environment for all our people. You will be part of a collaborative culture where progressive leadership, innovation, respect, and excellence are valued. Join a team of talented individuals who are passionate about what they do - achieving a more equitable world through better health.

We offer:

• A monthly accrued day off for full-time staff
• 14 weeks paid parental leave - no qualifying period
• Additional long service leave - 17.3 weeks (minimum is 8.67) at 10 years of service
• Study leave
• Flexible working arrangements
• Generous salary packaging
• Opportunities for career and professional development

Who are we?

Burnet Institute is a leading Australian, unaligned, not-for-profit, organisation passionate about social justice, equality and evidence-based research.

Burnet Institute brings together a highly diverse skill base, with more than 400 staff and students working across cutting-edge research and projects to address some of the most relevant global health issues. Institute-wide interdisciplinary health programs Disease Elimination, Health Security and Pandemic Preparedness, and Women's, Children's and Adolescents' Health are at the heart of our daily decision making. Harnessing our international and local field presence, our laboratories, and our mixed development and research cultures drives a greater focus on the most relevant health issues and achieves a greater impact as a result.

Whilst our headquarters is in Melbourne, Australia, we also have offices in Papua New Guinea and Myanmar, and are actively involved in research and public health programs throughout Australia, the Asia-Pacific region and Africa. Burnet is the only unaligned organisation in Australia that has dual accreditation with both the Australian National Health and Medical Research Council (NHMRC) and the Department of Foreign Affairs and Trade (DFAT).

Bring your whole self to work

At Burnet, we foster a diverse and inclusive culture. We want our people to feel like they belong and are free to be themselves at work. We have an active Gender Equity, Diversity & Inclusion (GEDI) Council that works to promote and improve gender equity, diversity and inclusion across the Institute, by developing and implementing strategies informed by both national and international best practice and staff input. Burnet holds an Athena SWAN Institutional Bronze Award from Science in Gender Equity (SAGE). If you have a reasonable adjustment, support, or access requirement at any stage of the recruitment process, we encourage you to let us know by emailing [email protected].

Sounds great! How do I apply?

Apply below and attach the following documents:

• Resume
• Cover Letter

Applications close at 11:59pm AEST on Wednesday, 02 July 2025.

As part of our commitment to gender equity, we have included a question in the application process on gender. This will allow us to monitor and report on gender in relation to our recruitment process.

Burnet is a child safe organisation. The successful applicant will be required to apply for a National Police Check and/or Working with Children. Current Australian working rights are required for all applicants.