Diagnostic Device Study Manager

2 weeks ago

Melbourne, Victoria, Australia beBeeClinicalResearch Full time $100,000 - $130,000
About Our Clinical Research Leadership Role

This pivotal position leads the planning, execution and management of clinical studies for innovative diagnostic devices as they progress toward regulatory submissions.

Key Responsibilities
  • Develop study protocols for ethics submission and review them thoroughly to ensure compliance.
  • Draft investigational brochures for ethics and regulatory approval, ensuring all necessary details are included.
  • Create, submit and manage ethics and governance applications and amendments efficiently.
  • Oversee trial documentation, case report forms, reports and essential files to maintain a smooth study process.
  • Identify and assess trial sites, including conducting site visits and engaging with investigators to ensure their involvement.
  • Ensure participant recruitment is on track and that study milestones are met in a timely manner.
  • Manage study operations, including clinical supply logistics, safety monitoring, adverse event reporting and audits to maintain the highest standards.
  • Apply ISO9001 principles and contribute to SOP development and quality documentation to enhance our processes.
  • Collaborate with research staff, investigators, industry partners and regulatory authorities to foster strong relationships and ensure successful outcomes.
  • Lead cross-functional teams, manage timelines, budgets and project deliverables effectively to drive results.
  • Provide regular verbal and written reports to management and stakeholders, keeping them informed of progress and any challenges.
  • Support data management practices, tools and software to ensure compliance and efficiency in our data handling processes.
Requirements
  • 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
About Our Organisation

We are a purpose-driven organisation with a strong alignment to health equity and improving outcomes for vulnerable communities. Our 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.

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