- Quality Management System: Design, implement and maintain a comprehensive Quality Management System (QMS) program to ensure consistency of practice to the highest quality standards across clinical trials, and to ensure compliance with ICH GCP, regulatory requirements, Ethics committees and Macquarie University (MQ) policies and procedures.
- Process Improvement: Drive system and process reviews and improvement initiatives to optimise trial quality and compliance.
- Audit and Inspection Management: Oversee preparation 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.
- Staff training: Oversee comprehensive training needs assessments and implementation and tracking of training programs meeting personal development requirements, as well as tracking and overseeing routine repeat trainings (ICH-GCP, Basic Life Support and safe laboratory sample handling and shipping etc).
- Workforce development: Oversee the clinical trial trainee program ensuring a pipeline of trained staff for entry level positions in the CTU.
- Leadership: contribute to strategic planning, team culture and CTU leadership and drive a continuous improvement culture and quality mindset in the CTU.
- Extensive clinical trial experience ideally including working on sponsored trials at a trial site
- Extensive 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
- Passionate about working in clinical trials
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Clinical Quality Manager - North Ryde, Australia - Macquarie University
Description
PRIMARY DETAIL
Appointment type: Full time, continuing
Salary Package: From $115,030 to $127,995 p.a. (HEW 8), plus 17% employers superannuation and annual leave loading
Flexible working arrangements e.g. a 9 day fortnight are available
Macquarie University (Wallumattagal Campus, North Ryde)
THE ROLE
The Clinical Trials Quality Manager is a leadership role providing clinical trial regulation expertise to ensure a continued focus on quality and compliance. The role is responsible for our quality management system, and coordination and tracking of staff training. It has 2 direct reports and 6 indirect reports:
About You
You will have extensive experience working on sponsored clinical trials ideally in a quality role. You will have experience managing, training and mentoring. You will have strong analytical skills with the ability to solve problems. You will have the ability to lead and deliver on projects involving risk management and process improvement in a clinical trial setting. You will be passionate about working in clinical trials.
About Us
The Clinical Trials Unit (CTU) is part of the Faculty of Medicine, Health and Human Sciences (FMHHS) at Macquarie University. FMHHS also has the Macquarie Medical School, the Macquarie University Private Hospital, and runs patient clinics, labs, imaging and a pharmacy all on campus in close proximity to support clinical trials, and support providing patients with access to state of the art treatments. The CTU undertakes sponsored and investigator initiated Phase I to IV trials across multiple therapeutic areas with multiple Principal Investigators. Our current team of over 60 staff (managing over 120 trials) are a close knit inclusive team with a supportive culture that values team work and innovation.
Macquarie is a university engaged with the real and often complex problems and opportunities that define our lives. Since our foundation 54 years ago, we have aspired to be a different type of university. Over the years, we've grown to become the centre of a vibrant local and global community. Connect with us today.
To apply
To be considered for this opportunity, please apply online and attach your resume and a separate cover letter that demonstrates how you meet to the selection criteria below:
Note: This position requires a criminal record check.
Eligibility for this position requires full work rights and Australian Citizenship or Permanent Residency.
Role Specific Enquiries: Nicola Chapman at
Note: This position requires you to comply with occupational screening, assessment and vaccinations in line with Macquarie University health requirements. You will also have to satisfy Macquarie University that you meet all background checks (including criminal record and working with children and qualification checks).
If you're already part of the Macquarie Group (MQ University, , MQ Health, MGSM), you'll need to apply through your employee Workday account. To apply for this job: Login to Workday and go to the Careers App > Find Jobs.
Applications Close:
12/05/2024 11:59 PM
Diversity and Inclusion
Innovation and ingenuity thrive at Macquarie University when diversity, equity and inclusion take centre stage. At the University, we embrace a culture where diversity of background, experience and perspective are fundamental to our success.
We do not discriminate on gender identity, age, culture, disability, sexuality, Indigeneity, family and caring responsibilities or religion. See our journey towards leadership in Equity, Diversity and Inclusion in Higher Education.
Flexible Work
At Macquarie, we believe by providing flexibility in when, where and how work is done, we can support our staff to manage their personal commitments, while optimising their work performance and contributions to the University. See how we lead in flexible work to enable an outcome focused and inclusive workplace. To learn more about our culture and hiring process, explore our Candidate Resource Hub.
