Senior Clinical Trial Specialist

6 days ago

Melbourne, Victoria, Australia beBeeResearch Full time $110,000 - $143,000

Clinical Research Manager

">Job Overview">

This pivotal position leads the planning, execution and management of clinical trials for innovative diagnostic devices as they progress toward regulatory submission. The successful candidate will oversee trial protocols, ethics and governance submissions, quality systems, and regulatory compliance to ensure trials are delivered to the highest standard.

">Main Responsibilities">
  • 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
">Required Skills and Qualifications">
  • 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
">About Our Organisation">

We are a purpose-driven organisation committed to health equity and improving outcomes for vulnerable communities. Our culture values inclusiveness, respect, and collaboration, providing a supportive and motivated workplace that encourages professional growth and impact.

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