Diagnostic Project Lead

2 weeks ago

Melbourne, Victoria, Australia beBeeClinicalResearch Full time $110,000 - $140,000
Lead Clinical Research and Operations Manager

This role is pivotal in leading the planning, execution, and management of a clinical study for an innovative diagnostic device as it progresses 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.

Key Responsibilities:

  • Develop, review, and finalize 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

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

Benefits:

  • Salary packaging available
  • Sign-on bonus considered
  • Opportunity to work on cutting-edge projects
  • Professional growth and development opportunities
  • Collaborative and supportive team environment

Culture:

The organization values inclusiveness, respect, and collaboration, with a culture that promotes health equity and improves outcomes for vulnerable communities.

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