Clinical Study Leader

3 days ago

Melbourne, Victoria, Australia beBeeClinicalResearchManager Full time $100,000 - $120,000
Job Title

A seasoned Clinical Research Manager is required to lead the planning, execution and management of clinical studies for innovative diagnostic devices.

Key Responsibilities:
  • Develop, review and finalise study protocols for ethics submission and regulatory approval.
  • Draft and manage investigational brochures for ethics and regulatory bodies.
  • 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.
  • 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 highly regarded.
  • 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.
Our Culture:

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

  • Clinical Research Study Leader

    3 days ago

    Melbourne, Victoria, Australia beBeeClinicalResearchStudy Full time $120,000 - $140,000

    Clinical Research Study Leader Job OpportunityThe role of Clinical Research Study Leader involves overseeing global clinical research studies, interacting with sponsors and sites, managing timelines and project deliverables, and coordinating all services contracted for the study.Main Responsibilities:Manage day-to-day operations of the project, ensuring...

  • Expert Clinical Study Leader

    5 days ago

    Melbourne, Victoria, Australia beBeeClinicalTrialManagement Full time $118,500 - $142,000

    Global Clinical Research LeadThe role of a Global Clinical Research Lead is to oversee and manage global clinical research studies in infectious disease. This position empowers project teams to lead and execute clinical trials with full-service solutions for clients.

  • Global Clinical Study Manager

    2 days ago

    Melbourne, Victoria, Australia beBeeClinicalResearch Full time $122,212 - $145,121

    Clinical Research LeadWe are seeking a highly skilled Clinical Research Lead to oversee global clinical research studies in our Melbourne, Australia office.Key Responsibilities:Manage project teams for multiservice global clinical trials.Interact with sponsors and manage timeline and project deliverables.Coordinate all services contracted for the study.Lead...

  • Clinical Trials Study Coordinator

    7 days ago

    Melbourne, Victoria, Australia Sinclair Dermatology Full time

    Introduction:About us:Sinclair Dermatology is a globally recognised medical centre headed by internationally renowned Dermatologist, Professor Rodney Sinclair.We see over 10,000 patients a year and house Australia's largest Dermatology research and clinical trials centre (Sinclair DIRECT).Our main office is conveniently located in East Melbourne with another...

  • Clinical Trials Study Coordinator

    5 days ago

    Melbourne, Victoria, Australia Sinclair Dermatology Full time

    Introduction:About us:Sinclair Dermatology is a globally recognised medical centre headed by internationally renowned Dermatologist, Professor Rodney Sinclair. We see over 10,000 patients a year and house Australia's largest Dermatology research and clinical trials centre (Sinclair DIRECT). Our main office is conveniently located in East Melbourne with...

  • Clinical Trials Study Coordinator

    5 hours ago

    Melbourne, Victoria, Australia Sinclair Dermatology Full time

    Introduction:About us:Sinclair Dermatology is a globally recognised medical centre headed by internationally renowned Dermatologist, Professor Rodney Sinclair. We see over 10,000 patients a year and house Australia's largest Dermatology research and clinical trials centre (Sinclair DIRECT). Our main office is conveniently located in East Melbourne with...

  • Global Clinical Study Lead

    2 days ago

    Melbourne, Victoria, Australia beBeeClinicalResearch Full time $120,000 - $140,000

    Clinical Research Professionals sought to lead global studies with our organization.The successful candidate will be responsible for overseeing the day-to-day operations of projects, ensuring compliance with ICH/GCP and relevant laws.This includes managing project teams, vendors, and site quality. The ideal candidate will have a strong understanding of...

  • Clinical Research Leader

    5 days ago

    Melbourne, Victoria, Australia beBeeResearch Full time $100,000 - $150,000

    Clinical Research LeaderMedpace is a leading full-service clinical contract research organization. We provide Phase I-IV clinical development services to biotechnology, pharmaceutical, and medical device industries.We leverage local regulatory and therapeutic expertise across major areas including oncology, cardiology, metabolic disease, endocrinology,...

  • Clinical Trials Study Coordinator

    2 days ago

    Melbourne, Victoria, Australia Sinclair Dermatology Full time

    Join to apply for the Clinical Trials Study Coordinator role at Sinclair Dermatology2 days ago Be among the first 25 applicantsJoin to apply for the Clinical Trials Study Coordinator role at Sinclair DermatologyGet AI-powered advice on this job and more exclusive features.About us:Sinclair Dermatology is a globally recognised medical centre headed by...

  • Lead Clinical Research Studies Manager

    2 days ago

    Melbourne, Victoria, Australia beBeeClinicalTrialManager Full time $118,950 - $155,550

    Clinical Trial Manager Role OverviewAs a seasoned clinical trial manager, you will lead global clinical research studies in infectious diseases. You will be the key contact for sponsors and sites, managing timelines and project deliverables.Key Responsibilities:Manage daily operations to ensure compliance with regulations and contracts.Act as primary sponsor...