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SalaryOur client who has close to 200 live clinical trials across a wide range of therapies including cancer, cardiovascular, respiratory, and neurological diseases are currently seeking a Clinical Trial Quality Manager.
The trials they conduct draw on the world class facilities at the associated Hospital, where they are situated, and the clinical expertise within the Faculty of Medicine and Health Sciences to deliver timely access for patients to novel therapies.The role:
This is a leadership role providing clinical trial regulation expertise to ensure a continued focus on quality and compliance. The role is responsible for maintaining the quality management system, and coordination and tracking of staff training and has 2 direct reports and 6 indirect reports.
This is an office-based position, located in Macquarie Park. The salary package includes 17 % superannuation, a flexible working arrangement of 35 hours work week/ 9 days fortnight* and discounted parking on site.Key responsibilities:
- Contribute to the design, implementation, and maintenance of the Quality Management System in line with ICH CGP requirements.
- Drive Process Improvement to continually optimise trial quality and compliance.
- Prepare for audits and inspections, and responses to audits and inspections to ensure appropriate follow up of any findings including sharing learning across relevant staff in the CTU.
- Maintain and roll out Standard Operating Procedures.
- Oversee training needs assessments and implementation and tracking of training programs meeting personal development requirements, including weekly Q&A sessions to ensure up to date knowledge and sharing of best practice.
- Oversee the clinical trial trainee program ensuring a pipeline of trained staff for entry level positions in the CTU.
- Contribute to strategic planning, team culture and CTU leadership and drive a continuous improvement culture and quality mindset.
- Extensive clinical trial experience ideally including working on sponsored trials at a trial site.
- Strong knowledge of clinical trials processes and Australian regulatory framework and international regulations and guidelines related to Phase I to IV clinical trials.
- Demonstrated experience leading and delivering on projects involved in risk management and process improvement in a clinical trial setting.
- Demonstrated experience managing, training and mentoring with a focus on continuous improvement and bringing the staff on the journey, with an open forum for feedback and ideas.
We are always interested to hear from talented and engaging people like you. Get in touch and tell us about yourself.Interested in this job?Save JobShare this JobCreate AlertSimilar JobsConsultant Name: Consultant Email: Social AccountsSCHEMA MARKUP ( This text will only show on the editor. )Welcome to On Q Recruitment, a specialist Sydney based Life Sciences and Government recruitment agency.
