Clinical Research Manager
Healthcare Professionals Group
- Melbourne, VIC
- $118,000-135,000 per year
- Permanent
- Full-time
- 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
- 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
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.