Clinical Trial Manager

STARS Education and Research Alliance Part-time (80%) fixed-term position through to September 2028 Base salary will be in the range $111,154 - $124.619 + 17% Superannuation (HEW Level 8) Based at the STARS Hospital building, Herston, Brisbane About This Opportunity We are seeking an experienced Clinical Trial Manager to join the Surgical Treatment and Rehabilitation Services (STARS) Education and Research Alliance team. In this role, you will provide specialised project management and clinical trial management skills for a national, multi-site, randomised clinical trial. The FISS-Australia Trial, funded by an NHMRC-NIHR Collaborative grant, will compare the clinical and cost-effectiveness of the Action Falls rehabilitation programme compared to usual care alone to reduce falls in stroke survivors. Our ideal candidate will be responsible for: Ensuring the highest standards of trial management, research governance and ethics compliance Developing, monitoring, and reporting on the project plan for the trial Drafting trial specific protocols and processes You will ensure that all aspects of the clinical trial are in accordance with Good Clinical Practice guidelines, Standard Operating Procedures, local and international regulatory requirements and that study specific requirements including protocols and ethically approved study-specific documents are adhered to. You will participate in collaborative multi-disciplinary research activities with internal and external collaborators, across trial sites in Queensland and other Australian states. You will participate in collaborative research activities with the FISS-UK trial team as we are conducting two trials in collaboration. Some interstate travel may be required to complete site visits. Key responsibilities will cover Clinical Trial Management, Clinical Research Projects, Governance and Reporting, and Leadership and Management. This will include, but is not limited to: Developing a project plan to meet funding and partner agreements, ensuring timely completion of project milestones Developing and managing research project documents (ethics and governance submissions, study protocols, case report forms, presentations for meetings) Performing clinical data review listings and summary tables, including query generation and resolutions management Establishing a project governance framework involving parties from the University, Queensland Health, and other trial partners Working with the onsite staff at partner hospitals and universities, leading the establishment and supporting ongoing operation of trial sites in accordance with SOPs, protocol, and all applicable regulatory guidelines Developing clinical trial project documentation e.g. Trial Master File (TMP), operating procedures, protocols, site initiation documentation, etc. Monitoring budgets and supporting the Chief Investigator with project finances Maintaining communication with collaborators, trial sites and key stakeholders, including organising and actively participating in meetings and trainings About UQ As part of the UQ community, you will have the opportunity to work alongside the brightest minds, who have joined us from all over the world. Everyone here has a role to play. As a member of our professional staff cohort, you will be actively involved in working towards our vision of a better world. By supporting the academic endeavour across teaching, research, and the student life, you will have the opportunity to contribute to activities that have a lasting impact on our community. Join a community where excellence is at the core of our culture, contributions are valued and a range of benefits and rewards are available, such as: 26 weeks paid parental leave or 14 weeks paid primary caregiver leave 17% superannuation contributions 17.5% annual leave loading Access to flexible working arrangements including hybrid working options and flexible start/finish times Health and wellness discounts – fitness passport access, free yearly flu vaccinations, discounted health insurance, and access to our Employee Assistance Program for staff and their immediate family UQ Study for Staff Salary packaging options About You Postgraduate Tertiary qualifications, preferably in a science or health care discipline or relevant senior experience working in a science or health setting. Previous and relevant experience working on clinical research projects within an academic, CRO or pharmaceutical environment. Strong experience in project management and conducting complex multi-site clinical trials in accordance with GCP methodology including evidence of management of project budget/s $1million. Experience in feasibility analyses, budget management, site start up and all aspects of trial management through to close-out activities. Demonstrated knowledge of Australian and international regulatory requirements for clinical trials and clinical research. Highly collaborative with good stakeholder management skills, strategic thinking and analytical skills, along with strong organisational, communication and planning skills. Excellent interpersonal skills and the ability to work well and flexibly with a wide range of varying stakeholders. Experience with the Redcap Database. Previous experience with clinical site initiations and clinical site monitoring. Strong focus on quality of work. Proficient in use of the Microsoft office suite and clinical trial management systems and an ability to learn new systems as required. Senior Clinical Research Associates, Project Managers and/or applicants with prior Contract Research Organisation experience will be highly regarded. The successful candidate may be required to complete a number of pre-employment checks, including: right to work in Australia, criminal check, education check, and mandatory immunisations. Work Rights You must maintain unrestricted work rights in Australia for the duration of this appointment to apply. Visa sponsorship is not available for this appointment. Relocating from interstate? There may be a possibility of a relocation support package. You can find out more about life in Australia's Sunshine State here. Questions? For more information about this opportunity, please contact Dr Emmah Doig at For application queries, please contact stating the job reference number (below) in the subject line. Want to Apply? All applicants must upload the following documents in order for your application to be considered: Cover letter summarising how your background aligns to the 'About You' section Resume Other Information UQ is committed to a fair, equitable and inclusive selection process, which recognises that some applicants may face additional barriers and challenges which have impacted and/or continue to impact their career trajectory. Candidates who don't meet all criteria are encouraged to apply and demonstrate their potential. The selection panel considers both potential and performance relative to opportunities when assessing suitability for the role. We know one of our strengths as an institution lies in our diverse colleagues. We're dedicated to equity, diversity, and inclusion, fostering an environment that mirrors our wider community. We're committed to attracting, retaining, and promoting diverse talent. Reach out to for accessibility support or adjustments. Applications close Sunday 3rd November 2024 at 11.00pm AEST (R-43497). Interviews are tentatively scheduled for week commencing 11th November 2024. #J-18808-Ljbffr