Clinical Study Leader

1 week ago

Melbourne, Victoria, Australia beBeeResearch Full time $126,960 - $148,848

As a key player in the diagnostics space, we are seeking a highly skilled and experienced Clinical Research Manager to lead our clinical studies with distinction.

The successful candidate will have a strong background in clinical governance, ethics submissions, and site coordination, with a proven track record of protocol writing, regulatory pathways, and investigational product planning.

With a Bachelor of Science or related discipline, you will have a minimum of 3 years' senior level experience in medical device or diagnostics clinical trials, with a strong focus on delivering high-quality results and driving business growth.

You will be an expert in project management, with a keen eye for detail and a collaborative approach that fosters strong relationships with research staff, investigators, industry partners, and regulatory authorities.

Additionally, you will possess excellent communication skills, with a customer-focused approach that drives engagement and satisfaction.

This is a pivotal role that requires a motivated and curious individual who is eager to develop within the diagnostics/IVD space.

Key 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 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

Culture:

Our organisation is purpose-driven, with a strong alignment to health equity and improving outcomes for vulnerable communities. We value inclusiveness, respect, and collaboration, creating a supportive and motivated workplace that encourages professional growth and impact.

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