Clinical Trials Manager

- Part-time (28 hours per week), Fixed term (36 months) position
- Based at our Lismore campus
- Flexible, inclusive work environment with generous remuneration and benefits

Southern Cross University is a dynamic, ambitious institution focused on its purpose of changing lives through revolutionary learning and research with real impact. Our game changing Southern Cross Model brings a deeper learning experience, improving individual student outcomes, quality of life and a better way to learn. Our world-ranked research is positively impacting our communities, environment and economy.

Working at Southern Cross University combines a rare combination of being surrounded by ambitious students, dedicated colleagues and an environment of stunning natural beauty. We are leaders in our communities in the Northern Rivers region of New South Wales, Coffs Harbour and the Gold Coast and we pride ourselves on helping shape a better tomorrow.

This is a world first project that will be conducting two clinical trials, the first one initially using compassion programs to help people in Northern Rivers who have experienced climate-related PTSD. The second trial will be a psychedelic trial over 2-3 sites with the aim to help people who still have resistant PTSD to help heal their relationship with nature and their mental health.

As the Clinical Trials Manager within our Faculty of Health, you will have a leadership position in coordinating the clinical trials. You will work closely with the Director, Healing Climate Trauma Initiative, and with the Research Assistant in coordinating the implementation of the clinical trials. This position is key to the project objectives.

We are seeking a Clinical Trials Manager to lead and manage two clinical trials, ensuring compliance with regulatory guidelines and maintaining participant safety and data integrity. The role involves overseeing and governing clinical trials, coordinating with internal and external collaborators, and managing multiple trials across various therapeutic areas to ensure timely and budget-compliant delivery.

The Clinical Trials Manager will support the trial's Grant Lead and Chief Investigators by providing strategic and operational advice associated with running the clinical trials and maintaining Good Clinical Practice (GCP) compliance.

  Core responsibilities include:

• Manage the Grants clinical trial activity, including engagement with community, industry, investigators, and health care providers to support negotiation and implementation of new trial agreements and sites.

• Develop and oversee the implementation of processes and documentation that guide the operations of the clinical trial/s in accordance with relevant compliance and regulatory protocol and guidelines, including standard operating procedures (SOPs) that include various forms of trial data and budget controls.
• Develop and build relationships with university academics, professional staff, researchers, industry representatives, regulatory bodies, and healthcare providers such as practice managers and GPs to ensure strong relationships and collaboration with all stakeholders.

The successful candidate will hold relevant tertiary qualifications, have extensive experience in leading or managing clinical trials, up-to-date Good Clinical Practice (ICH-GCP) certification, and a solid understanding of medical terminology. In addition, you have:

• Demonstrated experience in the mental health field with clinical trial systems (i.e. REDCap) contract and budget development, and project and trial management across multiple sites.
• Leadership and communication capabilities and success in driving team performance.
• Excellent organisational, analytical and problem-solving skills, with the proven capacity to make decisions, exercise discretion, confidentiality and diplomacy, and set and meet deadlines.
• Experience with trials using schedule 8 or 9 drugs and REDCap software experience would be advantageous.

Our staff benefit from flexible work arrangements, including hybrid work models, generous parental and carer’s leave provisions, wellbeing initiatives, employee assistance programs and professional learning opportunities. This position is:

• Part-time (28 hours per week, 0.8 FTE), fixed term (36 months)
• Located at our Lismore campus.
• HEW Level 7. The full-time equivalent base salary ranges from $99,711 - $108,268 per annum, plus 17% employer’s contribution to superannuation. The total remuneration package is up to $126,673.

Find out more about working at SCU by visiting Why Work at SCU.

Applicants must apply online and attach a CV and cover letter responding to the selection criteria within the position description by the closing date. Information to support you prepare your application is available on our website. If you experience difficulties applying online or need reasonable adjustments at any point in the application or interview process, please contact [email protected].  

Job applicants must be an Australian or New Zealand citizen, Australian permanent resident or currently hold a visa with ongoing work rights in Australia. Employer visa sponsorship is not available for this position.

Additional information is available in the position description or by contacting:

Name: Professor James Bennett-Levy

Email: [email protected]

Closing Date: 11.30pm AEST, 30 September 2024

Southern Cross University is committed to ensuring that the University reflects the rich diversity across the region in which the University’s campuses are located.

The University encourages applications from people of all ages, women, Aboriginal & Torres Strait Islander people, people living with disabilities, people from culturally and linguistically diverse backgrounds and people who are LGBTQI+.

We encourage applications from people with disability and will provide adjustments to the recruitment process upon request.

Use the position description link below to access further information about the selection criteria for this role. You will need to submit complete responses to the selection criteria with your application, including providing examples where relevant. Please prepare these and submit each response when prompted in your online application submission.