Job Overview Senior Clinical Project Manager / Lead Local Trial Manager – Global Clinical Operations (GCO) team. This permanent, full‑time role is based at North Ryde, New South Wales, Australia. You will work as the local point of contact for clinical trials within Australia, oversee project execution from feasibility through to close‑out, and support global teams to deliver trials on time, on budget and in compliance with GCP, SOPs and regulatory requirements. Responsibilities Lead country protocol and site feasibility assessments in collaboration with relevant stakeholders, ensuring adherence to local site selection criteria. Contribute to country‑level study management documents and support documentation for global studies as needed. Coordinate local trial team activities, ensuring compliance with SOPs and regulations while meeting recruitment targets and delivering high‑quality data within budget. Monitor trial progress, implementing corrective and preventive actions when necessary, and communicate issues to the study management team. Update trial management systems and analyze trial progress using available tools and reports. Facilitate and lead Investigator Meetings and local trial team meetings, providing training and support as necessary. Review and approve site and vendor invoices, manage local study supplies, and ensure compliance with informed consent and regulatory requirements. Act as the primary local contact for the trial, fostering strong relationships with both internal and external stakeholders. Act as a subject‑matter expert for assigned protocols and develop strong therapeutic knowledge. Mentor and guide junior team members, contributing to their training and development. Lead process improvement initiatives and take on additional responsibilities as a subject‑matter expert or champion for specific projects. Qualifications Degree in Science, Nursing or Life Sciences. Minimum of 6 years of clinical trial management experience, or a total of at least 8 years of clinical trial monitoring and/or clinical trial management experience. Therapeutic knowledge in Hematology and Oncology is highly regarded. Excellent communication and problem‑solving skills. In‑depth understanding of the drug development process including GCP and local regulatory requirements. Strong people leadership, coaching and mentoring, and customer focus. Demonstrated ability to lead initiatives or small teams. Willingness to travel. Benefits Competitive remuneration package. Continuous training and development. Award‑winning leadership development programs. Inclusive, flexible, and accessible working arrangements. Up to 18 weeks of parental leave. 4 days of volunteer leave. Option to purchase up to 2 weeks of additional annual leave. Dedicated Wellbeing Day. Global Wellness Reimbursement of $780 per year. Employee Assistance Program. Enhanced compassionate caregiver leave up to 30 days. Life insurance coverage. Other Information Equal opportunity employer supporting diversity and inclusion. Candidates must be authorised to work in New Zealand and not require visa sponsorship at the time of application. #J-18808-Ljbffr
Lead Local Trial Manager
7490-JANSSEN-CILAG PTY LTD LEGAL ENTITY
council of the city of sydney, council of the city of sydney
Published 4 days ago
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