Clinical Trial Project Manager
Vor 6 Tagen
Full time fixed term 2 years with possibility of extension (dependent on funding) Key Clinical Trial Project Manager role at the Institute of Musculoskeletal Health-Sydney School of Public Health. Base Salary $126,065 + 17% superannuation. About the opportunity Sydney School of Public Health is Australia's first and leading school of public health. Each day, our researchers and graduates are tackling global health challenges and striving to improve equity in communities locally and around the world. At the Institute for Musculoskeletal Health we bring together patients and clinicians with leading musculoskeletal health researchers to drive global improvements in health outcomes through increased understanding and management of musculoskeletal health and physical activity. Our researchers are in a strong position, backed by the resources and expertise of our partners, the University of Sydney and the Sydney Local Health District, to translate the university's research into positive outcomes for community health. We have an excellent opportunity for an experienced Clinical Trial Project Manager to support research in a number of projects, including the OASIS trial investigating the use of oral steroids in sciatica, the DREAM study investigating the use of anti‑depressant medicine to reduce sciatic pain, and other collaborative research projects including one with the Sydney Pharmacy School. Key Responsibilities Lead the end‑to‑end planning and comprehensive management of clinical trials from initiation to close‑out, ensuring efficient execution and alignment with study objectives, timelines and budget. Provide support, project management advice and reports to the Chief Investigators and the Study Steering Committees. Manage multiple concurrent projects, including the NHMRC‑funded OASIS and DREAM clinical trials, and other collaborations with the Sydney Pharmacy School. Provide clear leadership and direction to the team, acknowledging achievement, and fostering proactive problem‑solving and process improvement. Oversee and coordinate ethics applications, safety reporting, liaising with internal and external stakeholders including University departments and Local Health Districts. Coordinate clinical trial activities including recruitment activities, site selection and monitoring, investigational product management, data collection and drive compliance across study processes, ensuring adherence to national regulatory and ethical requirements and ICH GCP and applicable SOPs. Identify potential risks to project timelines and budgets, implementing contingency plans as necessary. Select and manage external vendors and service providers, ensuring quality standards and contractual obligations are met. Oversee reporting and compliance within the work area, ensuring accurate information on University systems. Contribute to the development of preliminary budgets and monitor expenditures against approved financial plans. Oversee resource management, balancing financial, personnel, and technology assets to ensure consistent delivery of services. Manage staff performance and development, including reviews, professional development, and career management (1–2 direct reports). Coordinate and manage risk assessment activities, prioritising workplace health and safety and ensuring alignment with University guidelines and best practices. Maintain effective communication with internal and external partners, facilitating discussions to address concerns and gather feedback. Utilise software tools such as REDCap, FileMaker, and the Microsoft Office suite to support trial management and reporting. Qualifications Bachelor's degree or higher in science, pharmacy, health, allied health, medicine, or an equivalent combination of relevant training and experience. Extensive experience in project management supporting clinical trials. Experience with drug intervention studies in primary care settings (highly regarded). Demonstrated ability to manage multiple projects simultaneously, including planning, budgeting, resource allocation, and meeting deadlines. Sound knowledge of ICH GCP Guidelines. Proficiency in trial management software and University systems, including REDCap and FileMaker. Proven stakeholder management skills, with experience engaging internal and external partners across universities and health districts. Excellent verbal and written communication skills, including the ability to liaise with diverse stakeholders. Flexibility and ability to travel between associated sites, University precincts and other locations, in line with role requirements. Excellent leadership capabilities, with experience managing staff performance and development. Strong organisational and problem‑solving skills, with a proactive approach to risk management and compliance. Must have unrestricted work rights in Australia for the duration of the employment. Sponsorship / Work Rights for Australia Visa sponsorship is not available for this appointment. Pre‑employment Checks Your employment is conditional upon the completion of all role required pre‑employment or background checks in a satisfactory manner to the University. Similarly, your ongoing employment is conditional upon the satisfactory maintenance of all relevant clearances and background check requirements. If you do not meet these conditions, the University may take any necessary step, including the termination of your employment. As this position is located on an NSW Health site, it is a regulatory requirement to complete compulsory employment checks prior to starting in this position. For more information and instructions, please visit: NSW Health employment requirements. EEO Statement At the University of Sydney, our shared values are trust, accountability and excellence and we strive to be a place where everyone can thrive. We are committed to creating a University community that thrives through diversity and reflects the wider community that we serve. We deliver on this through our commitment to diversity and inclusion, evidenced by our people and culture programs, as well as key strategies to increase participation and support the careers of Aboriginal and Torres Strait Islander People, women, people living with a disability, people from culturally and linguistically diverse backgrounds, and those who identify as LGBTQIA+. We welcome applications from candidates from all backgrounds. We are proud to be recognised as an Australian Workplace Equality Index (AWEI) Platinum Employer. Find out more about our work on diversity and inclusion. How to Apply Applications (including a cover letter, CV, and any additional supporting documentation) can be submitted via the Apply button at the top of the page. For employees of the University or contingent workers, please login into your Workday account and navigate to the Career icon on your Dashboard. Click on USYD Find Jobs and apply. For a confidential discussion about the role, or if you require reasonable adjustment or any documents in alternate formats, please contact Cecilia Blamey, Recruitment Operations by email to © The University of Sydney The University reserves the right not to proceed with any appointment. Click to view the Position Description for this role. Applications Close Applications Close Wednesday 10 December 59 PM #J-18808-Ljbffr
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