Be challenged and imagine with us

As the Global Clinical Trial Manager, you will oversee the operational activity for the ROADMAP trial within the Infection Research Program. ROADMAP is an NHMRC-funded Bayesian adaptive platform trial which aims to identify the most effective therapeutic strategies for patients with infected joint replacements (prosthetic joint infection). In ROADMAP, we will randomise over 2,500 patients, which will make it by far the largest ever RCT in this challenging condition. This role has a multinational reach, managing the activity of the trial in Australia, New Zealand, Canada, and the United Kingdom.

In this role you will:

• Co-ordinate and oversee all aspects of this complex global randomised trial.
• Sit on the global trial steering committee, and supervise all study staff.
• Develop study protocols, consent forms, case report forms (CRFs), and other clinical documentation.
• Design procedures for ethics and governance and oversee ethics approval and registration processes.
• Provide support to site investigators and research coordinators.

For a full list of role responsibilities, please see the Position Description.

This 1-year fixed term (with a view to extension for up to 5 years) position is full time and will be located at the at the Hunter Medical Research Institute (Awabakal and Worimi land).

This role will commence in January 2024.

How will you inspire us?

You will have:

• Proven experience successfully managing large-scale clinical trails end-to-end; experience with adaptive platform trials is highly regarded.
• The ability to build and maintain mutually beneficial relationships with internal and external stakeholders at all levels.
• Strong organisational and communication skills, including the ability to successfully oversee and communicate with stakeholders internationally and across multiple sites.

What we offer

The remuneration for this position is from $107,800 to $125,767 + 17% superannuation and is commensurate with skills and experience.

For information on our employee benefits (such as flexible working, discounts in private health insurance and gym memberships and salary packaging) please visit here.

About our University

The University of Newcastle stands as a global leader distinguished by a commitment to equity and excellence. Our vision is to be a world-leading University for our regions and creating a better future for our regions and the globe. Underpinned by this vision are our values of excellence, equity, engagement and sustainability.

The School of Medicine and Public Health sits within the College of Health and Wellbeing, and its main roles are teaching and research in the fields of clinical medicine and public health.

The Hunter Medical Research Institute (HMRI) is a partnership between the University of Newcastle, Hunter New England Health and the community. Within HMRI, there are 19 research programs. The Infection Research Program is one of the several new clinical research programs to be launched in 2022. Its vision is to reduce the impact of infectious diseases on human health by addressing important evidence gaps in the diagnosis, prevention, and management of infections.

We provide opportunities for all people regardless of their background and experience, and this philosophy is reflected across all that we do.

The University of Newcastle is an equal opportunity employer committed to equity, diversity and social inclusion. Women and Aboriginal and Torres Strait Islander candidates are particularly encouraged to apply.

Your next steps

Please visit here for a guide on how to apply for a role.

Please note, this role will commence in January 2024.

If viewing this on a job board other than the University's please click ‘Apply’ to reach the University's website, where a copy of the Position Description can be accessed. Please download a copy before commencing your application.

Your application must include:

• Your resume
• A cover letter outlining your motivation to apply for this opportunity
• A statement addressing the Criteria listed below

Essential

1. Post graduate qualification in nursing, science, health science or biomedical science or progress towards and extensive relevant experience or an equivalent combination of relevant experience and/or education/training.
2. Significant experience with responsible roles in the planning, conduct, coordination or management of clinical trials, and experience in managing international, multi-centre clinical trials.
3. Good working knowledge of medical and laboratory terminology, a sound understanding of the principles of Good Clinical Practice (GCP) and an excellent knowledge of applicable Australian and international regulations and guidelines.
4. Proficient computer skills related to project management with proven ability to manage central document repositories, GCP template documentation, ethics submissions and other regulatory and institutional documentation.
5. Effective organisational skills to plan and organise work to meet competing deadlines with the ability to work as both a member of a multi-disciplinary team and independently with minimal supervision, showing initiative and flexibility.
6. Outstanding oral communication and interpersonal skills with a demonstrated ability to liaise with and influence a diverse range of stakeholders, in order to achieve desired outcomes.

Desirable

1. Demonstrated experience with adaptive platform trial designs.
2. A higher degree in clinical trials research or clinical research methods (such as a Graduate Certificate, Diploma or Masters in Clinical Research or Public Health).
3. Significant direct experience in planning and managing large multicentre clinical trials.

Please upload your Cover Letter and response to the requested Criteria as one PDF document. Your Cover Letter and Response to the Essential Criteria should not exceed 2 pages.

For the full list of the selection criteria and role responsibilities, please download the Position Description (available in the Related Documents section below).

Contact Us

For specific position enquiries, please contact Professor Josh Davis, Head, Infection Research Program via email at josh.davis@newcastle.edu.au

Having Difficulties? Please reach out to us: employment@newcastle.edu.au

Extended Closing date: Monday 9 October 2023 at 11.59pm AEDT

We are excited to be Looking Ahead with you

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