Clinical Trial Manager

**Job no**: 0057744
**Location**:Parkville
**Role type**:Fixed-term for 9 months
**Faculty**:Faculty of Medicine, Dentistry and Health Sciences
**Department/School**:Department of Infectious Diseases
**Salary**:UOM 7 - $98,402 - $106,519 p.a. plus 17% super

The University of Melbourne would like to acknowledge and pay respect to the Traditional Owners of the lands upon which our campuses are situated, the Wurundjeri and Boon Wurrung Peoples, the Yorta Yorta Nation, the Dja Dja Wurrung People. We acknowledge that the land on which we meet and learn was the place of age-old ceremonies, of celebration, initiation and renewal, and that the local Aboriginal Peoples have had and continue to have a unique role in the life of these lands.

**About the Department of Infectious Diseases**

The Department of Infectious Diseases is a recently established department of the Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences that is based at The Peter Doherty Institute for Infection and Immunity (Doherty Institute). Research within the department encompasses infectious diseases including antimicrobial resistance and healthcare associated infections, malaria, HIV, tuberculosis, influenza, viral hepatitis, sexually-transmitted infections, skin pathogens and emerging infectious diseases such as COVID-19. Our researchers come from diverse backgrounds, including discovery research and basic scientists, clinician-researchers, epidemiologists, public health physicians and microbiologists.

**About the Role**

The Department of Infectious Diseases based at the Peter Doherty Institute for Infection and Immunity (the Doherty Institute) is seeking to appoint a Clinical Trial Manager (maternity cover).

A suitably qualified person is being sought to set up and manage a large international, multicentre clinical trial. The successful applicant will have the necessary skills to conduct ethics and regulatory submissions and operational aspects of a large clinical trial, including data management, safety and quality, and provide support to participating centres and site investigators and research coordinators for the duration of the trial.

Responsibilities include:

- Assist in development of study database establishment, design and functionality, data quality and entry
- Undertake Human Research Ethics Committee approval processes and trial registration
- Undertake participating site identification and recruitment
- Support investigators and project managers with operational aspects of research by developing appropriate procedures and processes

**About You**

You will have 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 mínimal supervision, showing initiative and flexibility. Your outstanding oral communication and interpersonal skills give you the demonstrated ability to liaise with and influence a diverse range of stakeholders, in order to achieve desired outcomes.

You will also have:

- 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
- Significant experience with responsible roles in the planning, conduct, coordination or management 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
- Current GCP accreditation

**Please note: To be considered for this role you must have current valid work rights for Australia.**
- To ensure the University continues to provide a safe environment for everyone, this position requires the incumbent to hold a current and valid Working with Children Check._

**About the University**
The University of Melbourne is consistently ranked amongst the leading universities in the world. We are proud of our people, our commitment to research and teaching excellence, and our global engagement.

**Benefits of Working with Us**
In addition to having the opportunity to grow and be challenged, and to be part of a vibrant campus life, our people enjoy a range of rewarding benefits:

- Flexible working arrangements, generous personal, parental and cultural leave
- Competitive remuneration, 17% super, salary packaging and leave loading
- Free and subsidised health and wellbeing services, and access to fitness and cultural clubs
- Discounts on a wide range of products and services inclu