Clinical Project Manager Organisational Context The Bionics Institute is passionate about multidisciplinary research and product development leading to clinical outcomes that improve lives. Our vision is to lead the world in innovative bionic health solutions through research, development, and translation. We are at an exciting phase, designing, implementing, and evaluating devices that assist in diagnosis and treatment of sensory deficits and neurological disorders. Our goal is to deliver benefits to people living with challenging health disorders by translating and commercialising our research outputs. We are at an exciting stage in our history. Our teams are expanding and we are branching out into new disease areas. We are developing multiple devices at different stages of research and development. The Clinical Project Manager has a crucial role to play in building our in-house clinical research capacity, and to ultimately ensure that our work ends up benefitting patients. Position Summary The purpose of this role is to ensure that all human research activities at the Bionics Institute comply with relevant regulatory requirements. You will be working closely with researchers and supporting project teams in all aspects of conduct and implementation of clinical trials. This role would assist researchers to comply with and understand the requirements of Good Clinical Practice (GCP). The Clinical Project Manager will also provide clinical trial knowledge and expertise to management at the Bionics Institute. We are looking for someone with initiative, who will be able to suggest improvements to our existing processes. You will have experience in clinical trials, ideally in investigator-initiated clinical trials. If you are a Clinical Research Associate looking to advance your career to the next level, this could be the role for you! You just need to be willing to roll up your sleeves and problem solve. Key Responsibilities • Manage the BI’s sponsor responsibilities for clinical trials and clinical research.• Identify and implement processes to ensure that BI’s clinical research is fully compliant with the relevant regulatory requirements.• Provide researchers with hands-on assistance in navigating ethics and governance application processes.• Establish and maintain information resources and training to aid researchers undertaking clinical research.• Use a risk management approach to improve BI’s clinical research activities. Key Selection Criteria Essential • Working experience in clinical trials management, as senior clinical trial coordinator, clinical research associate, clinical project manager, or similar role.• Relevant experience in the conduct, implementation or management of clinical trials.• Knowledge of clinical trial requirements across their lifecycle, from start-up to close out, including a detailed understanding of ICH GCP and the regulatory and ethical approval processes in Australia.• Experience in dealing with Human Research Ethics Committees and Research Governance Offices.• Knowledge of The National Statement on Ethical Conduct in Human Research• Strong organisational skills with an ability to prioritise work independently.• Strong initiative and communication skills.• Ability to interact with a range of stakeholders. Desired • Knowledge and experience of medical device standards, such as ISO 14155, ISO 14971, and TGA regulation of medical devices.• Experience in managing human research.• Understanding and experience negotiating clinical trial research agreements.• Experience in developing governance processes for clinical research.• Knowledge of the Australian Code for the Responsible Conduct of Research. Knowledge The incumbent is expected to understand the requirements of GCP, ethics committees, and undertaking a clinical trial. They will understand the legislation and guidelines relating to human research in Australia to ensure the Bionics Institute complies with relevant regulatory requirements. They will understand the structure and processes for establishing and maintaining a compliant framework for clinical trials and human research. Level of Supervision, Independence The incumbent is expected to carry out a range of tasks that require a high level of planning with excellent attention to detail. They are expected to exhibit initiative and flexibility in anticipating and responding to needs. The incumbent will have the ability to work autonomously with a collaborative and consultative style. Problem Solving, Judgement The incumbent will have a hands-on and pragmatic approach to identifying and proposing solutions. They will be able to identify and develop processes and procedures that are compliant with the relevant regulatory requirements. The incumbent will be able to develop and maintain resource information for researchers with the ability to implement training across the clinical trials and human research teams. Interpersonal and Organisational Skills The incumbent will require highly developed interpersonal and communication skills with an excellent command over written and verbal communication. They will need to be able to develop a quick rapport with a wide range of people, to communicate clearly and be able to have empathy with others, specifically being able to understand the researcher’s perspective. They must be able to be directive, as required, to ensure organisational compliance with policies, legislation and guidelines relating to human research in Australia. The incumbent must have strong organisational skills with an ability to prioritise work independently. They will be driven to continuously learn new skills and take on additional activities. The Clinical Project Manager position is a 3-year contract. A part-time position (0.8 FTE) may be considered. Requirements A police check is required.BI employees are required to be fully vaccinated against COVID-19. If you believe you meet the requirements for this position, please submit your application via SEEK. Please include a CV and a brief cover letter addressing the selection criteria. For a full position description please refer to our website: https://www.bionicsinstitute.org/vacant-positions Applications for the Clinical Project Manager will remain open until the position has been filled. Download full position description For further information about the Clinical Project Manager position, please contact the Head of Grants and Research Governance, Janine Clarey, by email: [email protected] Bionics Institute is an equal opportunity employer and female applicants are encouraged to apply. The Institute is committed to maintain a smoke free workplace and a workplace that is free from sexual harassment. The Bionics Institute’s workplace embraces the Occupational Health and Safety Standards.