Clinical Project Leader (BBBH35094) Macquarie Park, Sydney, Australia
| Salary: | 12% Performance Bonus |
Benefits
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
Duties
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
Culture
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.