Diagnostic Studies Manager

1 week ago

Melbourne, Victoria, Australia beBeeResearch Full time $116,418 - $152,587
About the Position

The successful candidate will oversee the planning, execution and management of clinical studies for innovative diagnostic devices as they progress toward regulatory submission.

Key responsibilities include developing, reviewing and finalising study protocols for ethics submission, drafting and managing investigational brochures for ethics and regulatory approval, creating, submitting and managing ethics and governance applications and amendments, and managing trial documentation, case report forms, reports and essential files.

In addition, the candidate will 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, and apply ISO9001 principles and contribute to SOP development and quality documentation.

The ideal candidate will have a Bachelor of Science/Biomedical Science or related discipline, with minimum 3 years' senior level experience in medical device or diagnostics clinical trials (IVD highly desirable).

The role requires 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, and experience with in-vitro diagnostic assay studies.

Strong project management skills, with experience using project management tools, good communication skills and stakeholder management, with a collaborative and customer-focused approach, motivated, curious, and eager to develop within the diagnostics/IVD space are also required.

This is an opportunity to join a purpose-driven organisation with a strong alignment to health equity and improving outcomes for vulnerable communities. The company culture values inclusiveness, respect, and collaboration, and provides a supportive and motivated workplace that encourages professional growth and impact.

  • Bachelor of Science/Biomedical Science or related discipline
  • Minimum 3 years' senior level experience in medical device or diagnostics clinical trials
  • 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
  • Strong project management skills
  • Good communication skills and stakeholder management

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