Clinical Trials Operations Manager

Hunter Medical Research Institute – New Lambton Heights NSW Advance research that transforms healthcare. At HMRI, we’re dedicated to improving the health and wellbeing of our community through world-class medical research. Our Clinical Trial Support Unit (CTSU) plays a vital role in enabling high-quality, patient-centred clinical research across the Hunter New England region. We are seeking a Clinical Trials Operations Manager to lead and coordinate clinical trial operations across HMRI and the Hunter New England Local Health District. This pivotal role provides operational leadership to the joint Hunter New England/HMRI CTSU and the HMRI Clinical Trial Coordinating Centre Team, ensuring efficient, ethical, and high-quality delivery of clinical trials that improve health outcomes for our communities. This is a full-time permanent position. Key Responsibilities Operational leadership: Oversee day-to-day operations of clinical trials and support the continuous development and implementation of standard operating procedures and best practices to ensure compliance, efficiency and quality. Stakeholder engagement: Build strong working relationships and act as a key liaison between HMRI and various stakeholders to align operational strategies and resolve any issues. Governance and compliance: Ensure adherence to Good Clinical Practice (GCP), ethical guidelines and regulatory requirements; provide lead response to audits and identify and manage project risks, issues and deviations. Team and resource management: Provide operational leadership and support, ensuring appropriate resource allocation and workload distribution to meet timelines and quality standards, whilst promoting a collaborative and high-performing team culture. Strategic contribution: Contribute to the development of systems and infrastructure that support scalable and sustainable trial delivery. Skills & Qualifications Demonstrated experience in managing clinical trial operations in a hospital, research institute/university, health service setting or similar. Bachelor’s Degree in either nursing, health sciences, allied health, data management or equivalent relevant experience and training. Strong knowledge of clinical trial regulations and ethical frameworks. Proficient in the use and implementation of CTMS and other systems relating to clinical trials and project management e.g. eREG. Experience in overseeing the delivery of all phases of Clinical Trials. Proven ability to lead teams, manage complex projects, and drive operational excellence. Sound leadership skills with the ability to influence change and deliver organisational goals in alignment with strategic objectives. Excellent interpersonal and communication skills, with the ability to build trust and collaborate across diverse teams. High level of organisational and problem-solving skills. Commitment to improving health outcomes through research and innovation. Cultural alignment with the values of collaboration, respect, integrity, and community impact. Strong understanding of the National Statement on Conduct of Human Research, National Clinical Trials Governance Framework, NSW Office for Health and Medical Research policies and guidelines, Privacy and Good Clinical Practice relating to the ethical conduct of human research and research governance. Why work for us? Flexible work options A chance to contribute meaningfully to medical research outcomes A supportive, team-oriented environment. How to Apply To apply, please submit your resume and a cover letter addressing your suitability for the role. For more information please contact ***********@hmri.org.au #J-18808-Ljbffr