Clinical Trials Quality Manager

PRIMARY DETAIL

Support ground-breaking research into a range of therapeutic areas in a busy trials unit. In order to support our CTU continuous quality improvement ethos, our growing team needs additional quality support. This part time job share position will contribute to the ongoing development and implementation of quality management systems and drive system and process improvement initiatives for clinical trials.

THE ROLE

• Appointment Type: Part-time (3 days per week), Fixed-term position for 2 years

• Total Remuneration Package: Up to (pro rata equivalent of) $144,400 p.a. inclusive of super and leave loading

• Location: Macquarie University (Wallumattagal Campus, North Ryde)

Reporting to the Head of Clinical Operations, this role will be responsible for supporting the fast paced Clinical Trials Team with:

• Establishing and refining systems, and processes for the conduct of phase I to IV clinical trials studies to ensure GCP compliance across all studies.

• Developing and delivering compliance training including contributing to staff onboarding,

• Regularly conducting and reporting on quality reviews to ensure quality oversight

• Facilitating the implementation of corrective and preventative actions (CAPAs), as required.

• Supporting the preparation and follow-up of GCP inspections

• Being a quality consultant for our Clinical Trial staff

• Facilitating the CTU clinical trial trainee staff program

• Actively participate on the CTU Executive Committee navigating the CTU strategy and direction.

About You

You will be a strong communicator and a critical thinker with an ability to lead and deliver projects in a clinical trial setting. You will have an in-depth knowledge and understanding of clinical trials processes, guidelines, and standards with hands-on experience in clinical trial audits and regulatory inspections ensuring site level GCP compliance and inspection readiness. Your rich knowledge base will make you a key point of contact for advice and support on best practice approaches and enable you to proactively evaluate inspection trends to drive process improvement initiatives and further enhance quality management activities.

If you are a proactive individual with a service and quality focus and can work collaboratively with others to achieve the team’s goals, you will thrive in this role and we welcome your application. 

About Us

The Macquarie University Clinical Trial Unit in the Faculty of Medicine, Health and Human Sciences was set up in January 2013 to provide patients with opportunities to participate in the latest medical advances in cancer treatment. The Program has since continued to grow with research into a range of therapeutic areas drawing from the University’s research centres and works closely with industry sponsors to deliver timely access to cutting-edge therapies and investigations into the prevention, diagnosis and treatment of a range of diseases. 

The Clinical Trials Program is strategically placed within a unique academic health environment co-located on campus, which encompasses Macquarie University Hospital (Australia’s only university-owned and operated hospital), private outpatient clinics and the medical research undertaken within the Faculty. Our team of over 40 supports patients in over 120 trials. 

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 position, please apply online and attach your resume and a cover letter that outlines how you meet to the selection criteria below:

• An in-depth understanding of clinical trials processes for phase I, II, III and IV clinical trials.

• Experience working as part of a clinical trial site (desirable )

• Strong communication skills with an ability to influence a diverse group of stakeholders at all levels.

• Ability to lead and deliver on projects involving risk management and process improvement in a clinical trial setting.

• Experience developing and delivering training material for clinical trial staff

• Knowledge and understanding of clinical research governance models and regulatory frameworks.

Role-Specific Enquiries: Nicola Chapman, Head of Clinical Operations, Clinical Trials at nicola.chapman@mq.edu.au

General Enquiries: Nithya Elango, HR Assistant at nithya.elango@mq.edu.au

Applications Close: 9 October 2022 at 11:55pm (AEST)

Note: Please note this position requires criminal record checking

If you’re already part of the Macquarie Group (MQ University, U@MQ, 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:

09/10/2022 11:59 PM

Equity & Diversity Statement

At Macquarie University, we are committed to providing a working environment where each individual is valued, respected and supported to progress. Our priority is to ensure culture, policies and processes are truly inclusive and that no-one is disadvantaged on the basis of their Aboriginal and Torres Strait Islander identity, gender, culture, disability, LGBTIQA+ identities, family and caring responsibilities, age, or religion. We encourage everyone who meets the selection criteria and shares Macquarie University’s values of scholarship, empowerment and integrity to apply.

Learn more about our progress towards Equity, Diversity and Inclusion.

https://staff.mq.edu.au/work/diversity-inclusion