• 2 years Part time /Fulltime contract opportunity available with possibility of extension.  
• Exciting opportunity for an experienced Clinical Trial Project Manager to join the Sydney School of Public Health working from the Royal Prince Alfred Hospital Precinct in Camperdown
• Base Salary HEO7 : $108,557- $118,267+ 17% superannuation

About the opportunity

About Sydney School of Public Health

Founded in 1930, 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.

Our vision is for a global community in which everyone's needs for good health and wellbeing are met. We actualise this vision by providing a wide range of education and research opportunities for students and academics. Our academics maximise the school's research impact by working alongside institutions such as the World Health Organization, the Gates Foundation and Australian governments at local, state and federal levels to bring the benefits of public health policy and practice to the people who need it most.

Primary function of the role:

The Clinical Trial Manager oversees the planning, initiation, and management of two NHMRC/MRFF-funded trials evaluating the management of musculoskeletal pain conditions in primary care. They direct the design of data collection tools, ensure quality data management, and uphold stringent regulatory compliance. They motivate and train site personnel, while prioritising collaboration and excellence. They ensure a focus on the principles of Good Clinical Practice. Therapeutic areas: Pain management in adults, musculoskeletal conditions, use of high risk medicines for pain.

Your key responsibilities will be to:

• Lead the structural and operational establishment of the trials and manage stakeholder engagement, ethics and governance.
• Prepare or contribute to high level budget estimates in response to Request for Services followed by detailed budget proposal.
• Oversee allocation and expenditure of budgets across the clinical trials within the assigned program and pursue funding and resourcing opportunities to support clinical trials.
• Ensure overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensure services are delivered per contract.
• Provide high-level strategic and managerial support to the clinical trial operations team.
• Contribute to the development and maintenance of systems, materials and procedures required to support the conduct of the two clinical trials.
• Ensure the trials are conducted according to relevant regulatory requirements and guidelines for best practice in clinical trials.
• Identify and mitigate potential risks and resolve protocol deviation issues.
• Work closely with the Principal Investigator, senior professional clinical trial staff, senior academics, and various internal and external stakeholders.
• Report on trial progress to the trial investigators.
• Work with researchers and sites to implement research protocols and provide day-to-day management support to the research team.
• Manage the preparation and submission of reports to the funder (NHMRC/MRFF), sponsor (University of Sydney) and ethics offices.
• Manage the establishment and maintenance of a research database.
• Supervise junior trial staff and oversee the recruitment of trial GPs across participating sites.

About you

• Bachelor degree with relevant experience in a health or science related field
• Extensive project management experience in clinical trials including managing budget, staff, stakeholders, ethics and trial governance (essential)
• Experience in managing trials in a general practice setting (essential)
• Experience with database and content management systems in a research, health or related environment (essential)
• Excellent decision-making and strong financial management skills
• Experience working with autonomy with execution of local trial management services, in-depth knowledge of the local trial management services and ability to process leadership
• You are enthusiastic, motivated to succeed and enjoy working with diverse groups of people, in a role that lets you foster a positive team culture and rewarding clinical trial outcomes
• Demonstrated experience contributing to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target
• Sites: Travel to sites is expected depending on the need within NSW and driving license is essential to the role
• Demonstrated experience in the supervision, training, mentoring and performance management of staff; and experience managing and resolving a diverse range of HR issues
• Superior knowledge of clinical trial requirements during their lifecycle from start up to close out, including a detailed understanding of the regulatory and ethical approval process across Australia
• Comprehensive knowledge of ICH Guidelines and Good Clinical Practice
• Demonstrated understanding of primary care, and the use of high risk medicines for pain (desirable)

To keep our community safe, please be aware of our COVID safety precautions which form our conditions of entry for all staff, students and visitors coming to campus.

We reward our employees with a terrific range of benefits which include:

Flexible work arrangements: varied start/finish times

Great leave conditions: one day off a month as an SDO, annual leave loading and paid parental leave for eligible staff members

Wellbeing programs: discounted gym membership (Fitness Passport)

Career development opportunities: Extensive free online training programs, study leave and internal development opportunities.

Sponsorship / work rights for Australia

Please note: Visa sponsorship is not available for this position. For a continuing position, you must be an Australian or New Zealand citizen or an Australian Permanent Resident.

Australian Temporary Residents currently employed at the University of Sydney may be considered for a fixed term contract for the length of their visa, depending on the requirements of the hiring area and the position.

Pre-employment checks

Your employment is conditional upon the completion of all role required pre-employment or background checks in terms satisfactory 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 include diversity and inclusion and we strive to be a place where everyone can thrive. We are committed to creating a University community which reflects the wider community that we serve. We deliver on this commitment through 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 LGBTIQ. We welcome applications from candidates from all backgrounds.

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.

If you are a current employee of the University or a contingent worker with access to Workday, 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 support filling out this application, please contact Faiza Khan, Recruitment Operations, by email to Faiza.khan@sydney.edu.au

© 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

Tuesday 16 July 2024 11:59 PM