Benefits

• Salary packaging available
• Sign-on bonus considered
• Be part of an organisation committed to health equity and impact

About the Company
This is a pivotal role leading the planning, execution and management of a clinical study for an innovative diagnostic device as it progresses toward regulatory submission. You will oversee trial protocols, ethics and governance submissions, quality systems, and regulatory compliance to ensure trials are delivered to the highest standard. The role will also involve supporting project management across other diagnostic initiatives, contributing to best practice implementation, and advancing medical knowledge. 

Duties

• Develop, review and finalise study protocols for ethics submission
• Draft and manage investigational brochures for ethics and regulatory approval
• Create, submit and manage ethics and governance applications and amendments
• Manage trial documentation, case report forms, reports and essential files
• Identify, assess and oversee trial sites, including site visits and investigator engagement
• Oversee participant recruitment and ensure study milestones are met
• Manage study operations including clinical supply logistics, safety monitoring, adverse event reporting and audits
• Apply ISO9001 principles and contribute to SOP development and quality documentation
• Collaborate with research staff, investigators, industry partners and regulatory authorities
• Lead cross-functional teams, manage timelines, budgets and project deliverables
• Provide verbal and written reports to management and stakeholders
• Support data management practices, tools and software to ensure compliance
• Travel to trial sites and relevant seminars/meetings as required

Skills and Experience

• Bachelor of Science/Biomedical Science or related discipline (essential)
• Minimum 3 years’ senior level experience in medical device or diagnostics clinical trials (IVD highly desirable)
• Strong knowledge of clinical governance, ethics submissions, and site coordination
• Proven ability in protocol writing, regulatory pathways, and investigational product planning
• Familiarity with ISO9001 quality systems and SOP development
• Experience with in-vitro diagnostic assay studies highly regarded
• Strong project management skills, with experience using project management tools (e.g., MS Project)
• Good communication skills and stakeholder management, with a collaborative and customer-focused approach
• Motivated, curious, and eager to develop within the diagnostics/IVD space

Culture
The organisation is purpose-driven, with a strong alignment to health equity and improving outcomes for vulnerable communities. Staff engagement is high, with a culture that values inclusiveness, respect, and collaboration. It is a supportive and motivated workplace that encourages professional growth and impact.

How to Apply Click apply or contact Georgia Graham – Senior Recruitment Consultant at +61 488 807 453 or ggraham@hpgconnect.com for a confidential discussion.