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Recruitment Consultant | Operations Manager | Project Manager
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 ISO**** 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 ISO**** quality systems and SOP development
Experience with in-vitro diagnostic assay studies highly regarded
Solid 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 ApplyClick apply or contactGeorgia Graham – Senior Recruitment Consultantat *************** or ****** for a confidential discussion.
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📌 Clinical Research Manager (Melbourne)
🏢 Healthcare Professionals Group
📍 Melbourne