Clinical Safety Manager
Clinical Safety Manager At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive better life outcomes for patients around the world. Care to join the team? GC CRO is a full-service oncology CRO specialising in radiopharmaceutical development. We help pharma and biotech companies accelerate drug development, facilitate collaborative research efforts, bridge the translational gap, enhance diagnostic capabilities, and engage a global network of medical experts. We are now seeking an experienced Clinical Safety Manager to take a lead role across clinical trial safety activities, owning end-to-end safety reporting for assigned studies and ensuring the highest standards of regulatory compliance. Reporting to the Senior Director, you will operate in a hands-on leadership capacity, with accountability for all safety reporting activities across multiple oncology clinical trials. This is a critical role where your expertise will directly influence patient safety, regulatory outcomes, and study success. You can be based in Sydney, Melbourne, Brisbane or Adelaide, with flexible work-from-home arrangements. In this role, you will: Lead and manage the Clinical Safety function, providing strategic, operational, and people leadership to ensure a high-performing, compliant, and inspection-ready safety department. Oversee end-to-end safety operations across clinical trials, including SAE and SUSAR management, medical review coordination, regulatory and ethics reporting, and ongoing safety oversight. Maintain oversight and ownership of the safety database, including study setup, data quality, system configuration, and ensuring the system remains compliant with regulatory and business requirements. Act as the primary point of accountability for safety governance, audit and inspection readiness, and safety-related Trial Master File (TMF) quality and compliance. Partner closely with Clinical Project Managers, Medical Monitors, and Sponsors to embed safety oversight into study delivery, risk management, and decision-making. Lead or act as Project Manager for safety-only projects and Sponsor engagements, ensuring delivery to scope, timelines, and regulatory expectations. Drive continuous improvement of safety processes, systems, and team capability within a lean CRO environment. To be successful in this role, you will bring: Tertiary qualifications in a science, life sciences or health discipline; Minimum of 7 years' experience in clinical research or regulatory roles, with at least 4 years' experience in clinical safety or pharmacovigilance within a CRO, pharmaceutical, or biotechnology environment. Demonstrated experience with safety databases and safety system oversight. Experience with TARA PV is highly desirable. Strong knowledge of global pharmacovigilance regulations and guidelines, including ICH E2A, E2B, E2F, and ICH-GCP. Experience supporting oncology clinical trials is highly desirable. Experience with line management and team leadership is preferred. Experience contributing to regulatory inspections, audits, and Sponsor oversight activities. Strong written, analytical, and presentation skills. Ability to work independently with minimal supervision, demonstrating sound judgement, ownership, and accountability for decision-making. Benefits of joining GC CRO & GenesisCare: Meaningful work that directly contributes to improved patient outcomes A collaborative, close-knit and purpose-driven team culture Flexible working arrangements to support worklife balance Internal and external training and professional development opportunities Award-winning learning and development programs Our Full Circle Wellbeing Program, supporting your physical, mental and financial wellbeing Free, confidential support services for you and your family (financial, legal, nutritional and wellbeing coaching) A range of employee benefits including Qantas membership discounts, access to My Fitness Passport, gym membership discounts, Bupa health insurance discounts and 12 weeks' paid parental leave. About GenesisCare: By joining GenesisCare, you will be joining a highly progressive and passionate team of healthcare professionals and support staff, united by a common purpose: to design care experiences that deliver the best possible life outcomes. The ambition for better cancer care that began our story, has grown into a passionate team of ~2,000 employees across 50 locations nationally. Join us to design better care and enjoy a career with purpose. GenesisCare is an Equal Opportunity Employer.
