Senior Clinical Study Manager

16 hours ago

Melbourne, Victoria, Australia beBeeClinicalResearchManager Full time $115,000 - $155,000

Job Opportunity

">

This pivotal role leads the planning, execution and management of a clinical study for an innovative diagnostic device as it progresses toward regulatory submission.

">
  • Draft study protocols for ethics submission
  • 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
  • Oversee participant recruitment
  • 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 and regulatory authorities
  • Lead cross-functional teams and manage project deliverables
  • Support data management practices
">

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
  • Strong project management skills
  • Good communication skills and stakeholder management
  • Motivated, curious and eager to develop within the diagnostics/IVD space
">

Our Culture

">

We value inclusiveness, respect and collaboration. It is a supportive and motivated workplace that encourages professional growth and impact.

"],

  • Clinical Trials Study Coordinator

    4 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...

  • Expert Clinical Study Leader

    2 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.

  • Clinical Trials Study Coordinator

    2 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...

  • Senior Clinical Operations Manager

    3 days ago

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

    Job OverviewAre you a strategic and forward-thinking professional with experience in clinical trial management?This is your chance to contribute to groundbreaking drug development as a Senior Site Manager. Join our dynamic team of innovators who are shaping the future of healthcare.We are seeking a skilled and motivated individual to lead site operations,...

  • Medical Writer II

    1 day ago

    Melbourne, Victoria, Australia Avance Clinical Pty Full time

    Medical Writer II / Senior Medical WriterWe\'re seeking an experienced regulatory Medical Writer to join us at MW II or Senior level. You can work remotely (WFH) from anywhere in Australia.OverviewAustralian based, regulatory Medical Writer II or Senior Medical Writer required. Remote, Hybrid or Office based working are all options.Who are we?We're Avance...

  • Medical Writer II

    20 hours ago

    Melbourne, Victoria, Australia Avance Clinical Pty Full time

    Medical Writer II / Senior Medical WriterWe/'re seeking an experienced regulatory Medical Writer to join us at MW II or Senior level. You can work remotely (WFH) from anywhere in Australia.OverviewAustralian based, regulatory Medical Writer II or Senior Medical Writer required. Remote, Hybrid or Office based working are all options.Who are we?We're Avance...

  • Clinical Trial Manager

    3 weeks ago

    Melbourne, Victoria, Australia Medpace Full time

    Join to apply for the Clinical Trial Manager (Oncology) role at Medpace Join to apply for the Clinical Trial Manager (Oncology) role at Medpace Get AI-powered advice on this job and more exclusive features.Medpace is currently looking for full time Clinical Trial Manager (CTM) to lead global clinical research studies.This position is based in our Melbourne,...

  • Clinical Trial Manager

    4 weeks ago

    Melbourne, Victoria, Australia Medpace Full time

    Clinical Trial Manager (Neuroscience/CNS)Join to apply for the Clinical Trial Manager (Neuroscience/CNS) role at MedpaceClinical Trial Manager (Neuroscience/CNS)2 weeks ago Be among the first 25 applicantsJoin to apply for the Clinical Trial Manager (Neuroscience/CNS) role at MedpaceGet AI-powered advice on this job and more exclusive features.Medpace is...

  • Clinical Trial Manager

    1 day ago

    Melbourne, Victoria, Australia Medpace Full time

    Clinical Trial Manager (Neuroscience/CNS)Join to apply for the Clinical Trial Manager (Neuroscience/CNS) role at MedpaceClinical Trial Manager (Neuroscience/CNS)2 weeks ago Be among the first 25 applicantsJoin to apply for the Clinical Trial Manager (Neuroscience/CNS) role at MedpaceGet AI-powered advice on this job and more exclusive features.Medpace is...

  • Senior Clinical Research Associate

    4 weeks ago

    Melbourne, Victoria, Australia IQVIA Full time

    Join to apply for the Senior Clinical Research Associate role at IQVIA1 day ago Be among the first 25 applicantsJoin to apply for the Senior Clinical Research Associate role at IQVIACurrently seeking Senior Clinical Research Associate for our Sponsor-dedicated team. Step into a dynamic role where you'll drive innovation and excellence in clinical research....