Job Title

1 day ago Be among the first 25 applicantsDirect message the job poster from Healthcare Professionals GroupRecruitment Consultant | Operations Manager | Project ManagerSalary packaging availableSign-on bonus consideredBe part of an organisation committed to health equity and impactAbout the CompanyThis is a pivotal role leading the planning, execution and management of a clinical study for an innovative diagnostic device as it progresses toward regulatory submission. You will oversee trial protocols, ethics and governance submissions, quality systems, and regulatory compliance to ensure trials are delivered to the highest standard. The role will also involve supporting project management across other diagnostic initiatives, contributing to best practice implementation, and advancing medical knowledge.DutiesDevelop, review and finalise study protocols for ethics submissionDraft and manage investigational brochures for ethics and regulatory approvalCreate, submit and manage ethics and governance applications and amendmentsManage trial documentation, case report forms, reports and essential filesIdentify, assess and oversee trial sites, including site visits and investigator engagementOversee participant recruitment and ensure study milestones are metManage study operations including clinical supply logistics, safety monitoring, adverse event reporting and auditsApply ISO9001 principles and contribute to SOP development and quality documentationCollaborate with research staff, investigators, industry partners and regulatory authoritiesLead cross-functional teams, manage timelines, budgets and project deliverablesProvide verbal and written reports to management and stakeholdersSupport data management practices, tools and software to ensure complianceTravel to trial sites and relevant seminars/meetings as requiredSkills and ExperienceBachelor 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 coordinationProven ability in protocol writing, regulatory pathways, and investigational product planningFamiliarity with ISO9001 quality systems and SOP developmentExperience with in-vitro diagnostic assay studies highly regardedStrong 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 approachMotivated, curious, and eager to develop within the diagnostics/IVD spaceCultureThe organisation is purpose-driven, with a strong alignment to health equity and improving outcomes for vulnerable communities. 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.How to Apply Click apply or contact Georgia Graham Senior Recruitment Consultant at +61 488 807 453 or [email protected] for a confidential discussion. #J-18808-Ljbffr