Full-time or part-time upto 1.0 FTE, 4 year fix term Principal Investigator Department of Cardiology Westmead Hospital

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1 Position Description POSITION TITLE Project Manager TYPE OF EMPLOYMENT Full-time or part-time upto 1.0 FTE, 4 year fix term REPORTING TO a) Principal Investigator DIVISION Department of Cardiology COMPANY Westmead Hospital REPORTING TO b) Director (for administrative purposes only) DIVISION Cardiovascular Division COMPANY The George Institute for Global Health DATE Sep 2015 The George Institute for Global Health The George Institute for Global Health is an internationally-recognised health research organisation, undertaking high-impact research across a broad landscape. Affiliated with several leading universities in Australia, Asia and the UK, the Institute is a global leader in research and policy on the prevention and treatment of common chronic and critical conditions such as diabetes, heart disease and severe trauma. The Institute was established in 1999 and employs a global network of leading medical experts across a range of specialties, as well as other health professionals with expertise in research design, project management and statistical analysis. With a respected voice among global health agencies, the Institute has attracted significant funding support from governments, foundations and corporations in support of its work. The George Institute s research is regularly published in the top tier of academic journals internationally and contributes to clinical and public health policy worldwide. Our mission is to improve the health of people worldwide by: Providing the best evidence to guide critical health decisions Engaging with decision makers to enact real change Targeting global epidemics, particularly of chronic diseases and injury Focusing on vulnerable populations in both rich and poor countries In achieving that mission, we are committed to ensuring the integration of good business practices throughout all our operations. The Institute has grown rapidly since its inception, and currently employs approximately 200 staff at its headquarters in Sydney. The George Institute also has offices in India, China and the UK at which an additional 100 staff are employed. Research is currently conducted at around 300 collaborating centres in approximately 50 countries worldwide. The George Institute is made up of several research & development themes, divisions and programs that oversee numerous large-scale international and regional projects funded by a diverse range of sponsors, both public and private. The George Institute has also established a number of social enterprises that provide services to clients in the healthcare, pharmaceutical and biotechnology sectors worldwide. In the current financial year, the Institute s gross revenue is expected to total around $90 million, making it one of the largest medical research institutes in Australia. 1

2 The George Institute is dedicated to the recruitment, development, and retention of the best people from around the world. The pursuit of academic, scientific and operational excellence in a can do culture is actively promoted in all our activities. For more information about the Institute, visit Our Values Humanitarian commitment to spur us in tackling health issues affecting high-risk and disadvantaged people worldwide. A focus on excellence to produce scientific evidence that is ethical and of high quality. Creativity to challenge traditional thinking and provide an impetus for new and innovative solutions to the world s leading health problems. Integrity to underpin our work and interactions, with collaborators and partners. A can do approach to produce timely, effective action, even in the face of adversity or other barriers to implementation. An emphasis on impact to ensure our work has real consequences for those who are most vulnerable to disease and injury. Western Sydney Local Health Network Western Sydney Local Health Network (WSLHN) is responsible for the provision of health services to the local government area comprised of Auburn, Baulkham Hills, Blacktown, Holroyd, and Parramatta, and tertiary care to the entire western region for an estimated population of 1 million people. These services are provided through a number of hospital and community-based facilities located strategically across the local health network. Westmead Hospital is a tertiary teaching hospital. Within the Cardiology Department at Westmead Hospital, there is a strong emphasis on clinical research. The Department has a large number of patients admitted with coronary artery disease and cardiac arrhythmia. Context The PROTECT-ICD Trial is a large randomized clinical trial, which will be conducted across Australia and New Zealand. The PROTECT-ICD Trial is an independent, investigator initiated, collaborative study between Western Sydney Local Health District (WSLHN) with Westmead Hospital as the primary site, and the George Institute for Global Health. The PROTECT-ICD Trial is a multi-centre trial targeting prevention of sudden cardiac death in patients who have had a heart attack. The trial aims to assess the role of electrophysiology study in guiding defibrillator implantation. The secondary aim of the trial is to assess the use of cardiac MRI in analysing heart function and predicting sudden death. The trial will recruit 1,058 patients from approximately 25 hospitals and will run for five (5) years. Role Purpose The PROTECT Trial Project Manager role is ideally suited for a well motivated, dynamic individual with a can do approach, who is interested in stepping up to be the primary person managing the whole aspect of an exciting international clinical trial that is likely to make a big impact on future patient care. The Project Manager is responsible for the development, conduct and completion of the PROTECT- ICD Trial in accordance with the reasonable requirements of the principal and associate investigator. This position will be based at Westmead Hospital for 100% of the time (Westmead, Sydney). This project manager position will primarily be focused on the PROTECT-ICD trial, but may be required to support other projects within Westmead Hospital as time permits. Reporting Relationships 2

3 The Project Manager reports to the Principal Investigator located at Westmead Hospital as well as the Director of the Cardiovascular Division at the George Insitute. The Project Manager will be instrumental in developing effective working relationships with the associate investigators and study coordinators at each hospital site. The Project Manager will supervise the Research Coordinator at Westmead Hospital and any other personnel reporting Key accountabilities All activities must be conducted in accordance with project specific documentation, ICH GCP and applicable regulatory requirements. Maintain effective professional relationships with investigators and vendors. Maintain effective professional relationships with internal project team including those providing academic input. Provide clear guidance to project team on project specific deliverables. Site Initiation and Management Coordinate the feasibility planning and selection process of project sites Liaise with various national and international sites to complete the necessary paperwork for site specific approval Organise site initiation visits by the Principal Investigator for overseas sites and by the Principal Investigator and the Project Manager for national sites. Facilitate training of Site Research Coordinator at each site regarding all aspects of the Trial. Have ongoing communication with each Site Research Coordinator regarding the management of the Trial. Prepare and distribute a monthly newsletter regarding the Trial to all the participating sites, to keep all updated about the status of the Trial and to maintain enthusiasm about the Trial. Coordinate and attend relevant Trial specific meetings Develop, review and approve, as applicable, Trial plan and other internal Trial management documents Assist the Principal Investigator in the development of Trial specific documents such as protocol and participant information forms as requested Financial Management Manage the budget allocated to the Trial Liaise with the Research Finance Manager at Westmead Hospital and Research Coordinator at individual sites to make payments to individual sites for trial participation, based on completeness of Trial data. Provide monthly updates to the Principal Investigator regarding the transactions from the Trial Cost Centre. Personnel Management Supervise the Research Coordinator at Westmead Hospital in the recruitment of patients for the Trial. Supervise any other person who might be reporting to you. Project Implementation and Closure Manage the implementation, ongoing evaluation, prioritisation, reporting and timely delivery of all operational aspects of allocated project/s including: - prepare (if applicable) and manage and track project specific budget - track project scope and propose scope changes for assessment - work with relevant personnel to identify potential clinical sites, oversee or conduct feasibility through questionnaire, interview and/or site visit as applicable. Oversee the set-up of sites within relevant region in accordance with SOPs, protocol and all applicable regulatory guidelines. 3

4 Identify and arrange all required materials for project Monitor project progress against timelines and report this both internally and to the originator of the project Deliver project specific milestones as agreed with the originator of the project Coordinate project administration, for example study management committee meetings and project newsletters Coordinate and drive allocated project team to meet project specific deadlines. If required liaise with centre staff to ensure effective local management Drive project team to deliver clean, accurate and verifiable data for interim/final analyses Oversee the development of project specific documentation, for example site manuals, operating procedures Review and sign-off monitoring visit reports Ensure patient safety and adverse/serious adverse events are reported according to regulatory requirements Initiate filing conventions for the project and ensure team is trained on all requirements File and archive clinical project data and all associated documentation at end of project At the end of the project ensure full reconciliation of all project specific supplies Maintain contact with Site Coordinators and project specific committee members as required by the originator of the project Be available as back-up contact for site staff on all project related matters Where applicable liaise with staff in other departments such as Data Management and Statistics, on project specific deliverables Coordinate and attend relevant project specific meetings throughout the project Coordinate and manage Regional Coordinating Centers (RCC) and RCC PMs/CRAs Line manage CRAs, CTAs, Research Fellows Systems and training Mandatory attendance at core department and project specific training Attend and actively participate in project management and organisational meetings and workshops Comply with all required project specific systems. Comply with all applicable regulations, guidelines, and project specific requirements. Complete and document all necessary training in these. Ensure project team members have access to necessary project specific training. Contribute ideas and experiences to improve processes/tools, systems and organisation. Occupational Health and Safety Comply with OH&S legislation and operate in accordance with established OH&S practice and procedures at Westmead Promote and contribute to a safe, secure environment for staff and visitors. Skills, Knowledge and Experience Tertiary qualifications in a related science or health care discipline. Ability to work autonomously on all aspects of a multi-centre international clinical trial of critical significance Previous experience working on clinical projects within an academic, CRO or pharmaceutical environment. Previous experience supervising project related tasks of other people. Previous experience with HREC (human research and ethics committee) and SSA (site specific assessment) application and approval processes 4

5 Excellent interpersonal skills and ability to work well and flexibly with a wide range of varying stakeholders. High level of oral and written English communication skills. Working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions. Technological proficiency including Microsoft Office suite (Word, Excel, PowerPoint, Outlook, Project), clinical trials management software, electronic CRFs and the Internet. Sound understanding of medical terminology Ability to travel (up to 10%) 5