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Clinical Research Manager
Clinical Research ManagerBurnet Institute • City of Melbourne, Victoria, Australia
Clinical Research Manager

Clinical Research Manager

Burnet Institute • City of Melbourne, Victoria, Australia
5 days ago
Job description

We have an exciting opportunity for a Clinical Research Manager to join the Burnet Diagnostics Initiative team at Burnet.

In this role you will oversee the design, planning, execution, and management of clinical trials and research studies, ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), and ethical standards. You will coordinate cross‑functional teams, support budget reporting, maintain timelines, and contribute to high‑quality research outcomes. You will also collaborate with investigators, regulatory authorities, and industry partners to ensure studies and trials are conducted efficiently and effectively.

Responsibilities

  • Lead end‑to‑end management of clinical studies / trials, including protocol development, study initiation, monitoring, data collection and close‑out.
  • Prepare, manage and maintain clinical study documentation including protocols, consent forms, reports and case report forms.
  • Create, submit and manage ethics and governance applications and amendments.
  • Manage clinical operations including study planning, logistics, data / sample / document management and quality assurance.
  • Collaborate with research staff, principal investigators, industry partners, regulatory agencies and other stakeholders.
  • Oversee site selection and conduct / coordinate site visits.
  • Train research staff and support adherence to best practice.
  • Conduct monitoring, audits, safety reporting and data quality checks.
  • Lead project management activities including scope, milestones, deliverables, documentation and reporting.

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 part‑time working from home option.

Essential Qualifications

  • Bachelor of Science / Biomedical Science degree in a biological or clinical laboratory discipline.
  • Minimum three years’ senior‑level experience managing IVD, medical device or therapeutic product clinical studies / trials.
  • Strong understanding of ICH‑GCP, clinical study / trial design and regulatory pathways (TGA, IVDR, FDA).
  • Excellent leadership, organisational and problem‑solving skills.
  • Demonstrated ability to manage multiple projects and work collaboratively with multi‑functional teams.
  • Proficiency in EDC systems and CTMS.
  • Demonstrated experience using project management tools (e.g., MS Project).
  • Desirable (but not essential)

  • Experience independently designing and managing pivotal IVD clinical studies / trials for regulatory submission.
  • Strong knowledge of ISO 14155.
  • Post‑graduate qualification in biological or clinical laboratory disciplines.
  • 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.

    Benefits

  • A monthly accrued day off for full‑time staff
  • 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.

    We bring 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.

    We are committed to inclusivity and diversity. If you have a reasonable adjustment, support, or access requirement at any stage of the recruitment process, please let us know by emailing careers@burnet.edu.au.

    Applications close at 11 : 59pm AEDT on Tuesday, 02 December 2025.

    Applicants must submit a resume.

    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.

    Seniority level : Associate

    Employment type : Contract

    Job function : Research, Industry : Research Services

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    Research Manager • City of Melbourne, Victoria, Australia

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