Clinical Data Manager

Clinical Data Manager

Melanoma Institute Australia (MIA) is an independent, non - profit organisation located in North Sydney. MIA is formally affiliated with the University of Sydney and collaborates with individuals at St Vincent's and Mater Health, Royal Prince Alfred Hospital and at the University of Sydney to improve the outcome of patients with melanoma. Each year around 2,000 new melanoma patients are referred to MIA and approximately 20,000 patient visits per annum.

MIA is seeking a Clinical Data Manager (CDM); the role is responsible for the data review activities of investigator-initiated trials (IIT) sponsored by MIA.

The CDM will support the Chief Investigators, Clinical Trials Operations Manager and the research team in the delivery and implementation of Investigator Initiated Trials (IITs) within an academic/not-for-profit setting. Key responsibilities are:

• Ensure data quality and accuracy by conducting data review activities
• Develop and maintain data validation plans and data entry guidelines
• Design electronic Case Reform Forms (eCRF) and manage the design, development, testing, and maintenance, of electronic data capture (EDC) systems for clinical trials.
• Produce data reports for active trials, continuously monitor data quality and ensure timely and accurate data collection.

The CDM provides input during the development of the clinical study documents, having the opportunity to impact all stages of the clinical research process.

• To succeed, preference will be given to having prior experience in Clinical Data management within a regulatory clinical trial environment
• The ability to work well in a project team, adaptability and flexibility
• High level problem solving, conceptual and analytical skills paired with excellent interpersonal and communication proficiency
• Strong operational and planning skills in order to meet deadlines and to handle multiple studies.
• Must be accurate with an excellent attention to detail and a methodical approach to work.
• Strong computer skills in MS Office applications, particularly in Excel and email.
• Equally important will be your knowledge of the regulatory legislation surrounding clinical trials, ICH-GCP and associated protocols.

This is an outstanding opportunity to further your career and develop your skills in a globally recognised institution. You will enjoy achieving outcomes across all stages of the clinical trials and will find great satisfaction in supporting cancer research projects.

As we are considered a health facility, for us to accept your application, you must be fully vaccinated against COVID19. Only applicants with full working rights within Australia should apply. Only successful applicants will be contacted. Please no recruitment agencies.

We pay our respects to the Traditional Custodians of the lands on which Melanoma Institute Australia works, and their Elders both past and present, and acknowledge the deep, continuing connection of Aboriginal and Torres Strait Islander peoples to the land, waters, and sky.