Clinical Trial Manager

2 days ago

Parkville, Australia University of Melbourne Full time

About the Role

The Department of Infectious Diseases at the Doherty Institute seeks a Clinical Trial Manager for the Australasian COVID-19 (ASCOT) trial, an international, multicentre study aimed at improving outcomes for hospitalised COVID-19 patients. The role involves managing ethics and regulatory submissions, data management, safety, and quality, and coordinating with another adaptive trial at Monash University (REMAP-CAP). This position offers a unique opportunity to manage an adaptive platform trial and collaborate with an experienced research team.

Your responsibilities will include:

Assume overall responsibility for the preparation and maintenance of template documentation for study protocols, case report forms, informed consent forms, operational and regulatory documents, and other clinical research documentation as necessary.  Develop procedures, documentation and training to support investigators and research coordinators at recruiting sites.  Work with the REMAP-CAP team to ensure studies procedures (where applicable), outcomes and data capture systems align.  Conduct data quality monitoring, site audit monitoring and site visits. Undertake Human Research Ethics Committee approval processes and trial registration.

Who We Are Looking For
The ideal candidate excels in attention to detail, communication, stakeholder management, and interpersonal skills, with strong organisational abilities to effectively manage tasks and relationships.

You will also have:

Post graduate qualification in science, health science, biomedical science or nursing or progress towards and extensive relevant experience or an equivalent combination of relevant experience and/or education/training. Significant experience with responsible roles in planning, conduct, management or coordination of clinical research, including clinical trials, and experience in managing international, multi-centre clinical trials. 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. 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.

For further information regarding responsibilities and requirements, please refer to the attached PD.

Please note: Visa sponsorship is not available for this position . This role requires current valid work rights for Australia.

Your New Team – Department of Infectious Diseases
The Department of Infectious Diseases at the Peter Doherty Institute conducts impactful research on global health challenges, including antimicrobial resistance, HIV, tuberculosis, and emerging infectious diseases. Join our collaborative team of diverse researchers, make a difference in patient outcomes, and contribute to shaping public health policies. Together, we strive for excellence, innovation, and integrity in advancing our understanding and combatting infectious diseases.

What We Offer You In addition, we offer the opportunity to be part of a vibrant community and enjoy a range of benefits, including generous leave provisions, salary packaging, health and well-being services and discounts on graduate courses. For more information, check out our benefits page

About the University of Melbourne
We’re tightly connected with the community, both at home and abroad. We take pride in our people, who all contribute to our mission to benefit society through the transformative impact of education and research. Discover more via our website and stay connected with our stories and people on LinkedIn.

We are dedicated to ensuring barrier free and inclusive practices to recruit the most talented candidates. If you require reasonable adjustments, please contact the employee listed on the first page of the Position Description found below, with an email containing your name and contact details for a confidential discussion. Please ensure your email is titled "Reasonable Adjustments Request".

Aboriginal and Torres Strait Islander Applicants
 We aspire to be the University of choice for Indigenous Australians, with unprecedented investment to attract, nurture and retain Aboriginal and Torres Strait Islander students and staff. Tangible support through a range of programs and initiatives will ensure that you personally succeed and flourish while at the University of Melbourne.

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