A step-up opportunity for a CRA
Gain project management experience
Work for a global company
Minimal travel at 30%-40%
Flexible working arrangements
About the company
A global healthcare company and a market leader
About the opportunity
The focus of this position is the management and co-ordination of clinical research projects across all phases
of clinical development
Assessing the feasibility, logistics, timeframes, and budget of clinical studies
Designing the study protocol local clinical trials
Writing and reviewing of study reports/presentations
Coordinating the preparation of documentation for Ethics and Governance submissions
Collecting and maintaining regulatory documentation
Identifying and selecting investigators to undertake clinical trials, arranging and participating in meetings
Mentor / coach CRAs including regular site visits
Liaise with the CRAs to ensure that the documentation for each clinical study is complete, and correct within set time frames
Reporting & follow up of Serious Adverse Events (SAE)
Skills and Experience
Nursing or biological science qualification
>5 years experience in medical device industry
Minimum of 3 years monitoring experience
Knowledge of TGA regulations for clinical trials and adverse event reporting requirements
Ability to effectively identify, plan, schedule and co-ordinates the resources required to accomplish goals
A dynamic and supportive culture that are focused on employee training and development
How to Apply
Click apply or contact Christine Bristol, Executive Consultant on +61 2 8877 8766 for a confidential discussion.
15 days ago
- Macquarie Park
About the company A bio-pharmaceutical company engaged in the research, development, manufacture and supply of medicines that aim to make a real difference to the lives of AustraliansAbout the opportunity The Clinical Project Manager will lead the local study teams to deliver committed components of clinical studies according to agreed resources, budget ...
28 days ago
About the CompanyOur client is a full-service clinical contract research organisation (CRO), who cover phases I-IV across biotechnology, pharmaceutical and medical device industries. This company works within all major therapeutic areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. This company...
19 days ago
- New South Wales
- Attractive Salary Package
About the companyAn ASX-listed, Australian clinical-stage, biotechnology company focused on the development of a novel drug candidate for the treatment of neurodegenerative diseases. About the opportunity The Director of Drug Development is responsible for the planning, i...
28 days ago
About the Company Our client is a full-service clinical contract research organisation (CRO), who cover phases I-IV across biotechnology, pharmaceutical and medical device industries. This company covers all major therapeutic areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.