Head of Quality

Updated: over 2 years ago
Location: Sydney, NEW SOUTH WALES
Job Type: FullTime
Deadline: The position may have been removed or expired!

  • Exciting opportunity to join the NHMRC Clinical Trials Centre of the University of Sydney in a new role – Head of Quality

  • Located at the Medical Foundation Building within Camperdown Campus

  • Full time fixed term until October 2023, base Salary $127000 - $134000 + 17% superannuation

About the opportunity

The NHMRC Clinical Trials Centre (CTC) is a Flagship Academic Research Organisation (ARO) within the Faculty of Medicine & Health, University of Sydney. The CTC conducts research to improve global health outcomes, bringing together world-leading experts in clinical trials (design, methods, conduct), biostatistics, patient-reported outcomes, health economics, translational research, research synthesis, and health technology assessment. The Clinical Trials Program at CTC specialises in developing and conducting large, multicentre, and international investigator-initiated clinical trials covering a broad range of therapeutic areas including oncology, cardiology, diabetology, nephrology, neonatal and perinatal health, as well as projects investigating treatments for COVID-19.

The Head of Quality directs, oversees, and supports activities to ensure quality assurance and compliance of NHMRC Clinical Trials Centre (CTC) clinical trials and other CTC research activities with USyd policies, CTC Standard Operating Procedures (SOPs), and relevant regulatory, ethical, and other industry standards as relevant to academic investigator-initiated studies.

Your key responsibilities will be to:

  • work under the broad direction of the Director, Clinical Trial Operations and Development

  • manage the CTC Quality program to ensure compliance with best practices for clinical trial and research activities.

  • provide expert guidance and input into clinical trials/research project plans regarding Quality Assurance and Quality Control requirements and plans

  • build and maintain good working relationships with internal stakeholders i.e. quality team, program managers, clinical trial project leads, functional heads, and external collaborators.

About you

  • a Bachelor’s qualification within health, medicine or extensive experience in a related field

  • extensive knowledge of clinical trial requirements during their lifecycle from start up to close out, including a detailed understanding of the regulatory, ethical and governance processes and requirements in Australia

  • an extensive background in clinical trial and/or working knowledge of ICH Good Clinical Practice

  • demonstrated initiative and ability to adopt sound judgement to coordinate the multi-faceted program with multiple activities and teams concurrently and resolve complex issues

  • has leadership ability to guide, develop and manage a high performing and multi-disciplinary team, including managing performance and development, and for the delegation of work activity

  • ISO 9000 certification is not essential but also highly regarded.

Closing date for applications

11.59pm, 18 October 2021

Sponsorship / work rights for Australia

Please note: Visa sponsorship is not available for this position. For a continuing position, you must be an Australian or New Zealand citizen or an Australian Permanent Resident.

Australian Temporary Residents currently employed at the University of Sydney may be considered for a fixed term contract for the length of their visa, depending on the requirements of the hiring area and the position.

Pre-employment checks

Your employment is conditional upon the completion of all role required pre-employment or background checks in terms satisfactory to the University. Similarly, your ongoing employment is conditional upon the satisfactory maintenance of all relevant clearances and background check requirements. If you do not meet these conditions, the University may take any necessary step, including the termination of your employment.

EEO statement

The University of Sydney is committed to diversity and social inclusion. Applications from people of culturally and linguistically diverse backgrounds; equity target groups including women, people with disabilities, people who identify as LGBTIQ; and people of Aboriginal and Torres Strait Islander descent, are encouraged.

How to apply

Applications (including a cover letter, CV, and any additional supporting documentation) can be submitted via the Apply button at the top of the page.  

For employees of the University or contingent workers, please login into your Workday account and navigate to the Career icon on your Dashboard.  Click on USYD Find Jobs and apply.

For a confidential discussion about the role, or if you require reasonable adjustment or support filling out this application, please contact Cathy Roll, Recruitment Operations, by email to [email protected]

© The University of Sydney

The University reserves the right not to proceed with any appointment.

Click to view the Position Description for
this role.

Closing Date: 18 October 2021

  • Exciting opportunity to join the NHMRC Clinical Trials Centre of the University of Sydney in a new role – Head of Quality

  • Located at the Medical Foundation Building within Camperdown Campus

  • Full time fixed term until October 2023, base Salary $127000 - $134000 + 17% superannuation

About the opportunity

The NHMRC Clinical Trials Centre (CTC) is a Flagship Academic Research Organisation (ARO) within the Faculty of Medicine & Health, University of Sydney. The CTC conducts research to improve global health outcomes, bringing together world-leading experts in clinical trials (design, methods, conduct), biostatistics, patient-reported outcomes, health economics, translational research, research synthesis, and health technology assessment. The Clinical Trials Program at CTC specialises in developing and conducting large, multicentre, and international investigator-initiated clinical trials covering a broad range of therapeutic areas including oncology, cardiology, diabetology, nephrology, neonatal and perinatal health, as well as projects investigating treatments for COVID-19.

The Head of Quality directs, oversees, and supports activities to ensure quality assurance and compliance of NHMRC Clinical Trials Centre (CTC) clinical trials and other CTC research activities with USyd policies, CTC Standard Operating Procedures (SOPs), and relevant regulatory, ethical, and other industry standards as relevant to academic investigator-initiated studies.

Your key responsibilities will be to:

  • work under the broad direction of the Director, Clinical Trial Operations and Development

  • manage the CTC Quality program to ensure compliance with best practices for clinical trial and research activities.

  • provide expert guidance and input into clinical trials/research project plans regarding Quality Assurance and Quality Control requirements and plans

  • build and maintain good working relationships with internal stakeholders i.e. quality team, program managers, clinical trial project leads, functional heads, and external collaborators.

About you

  • a Bachelor’s qualification within health, medicine or extensive experience in a related field

  • extensive knowledge of clinical trial requirements during their lifecycle from start up to close out, including a detailed understanding of the regulatory, ethical and governance processes and requirements in Australia

  • an extensive background in clinical trial and/or working knowledge of ICH Good Clinical Practice

  • demonstrated initiative and ability to adopt sound judgement to coordinate the multi-faceted program with multiple activities and teams concurrently and resolve complex issues

  • has leadership ability to guide, develop and manage a high performing and multi-disciplinary team, including managing performance and development, and for the delegation of work activity

  • ISO 9000 certification is not essential but also highly regarded.

Closing date for applications

11.59pm, 18 October 2021

Sponsorship / work rights for Australia

Please note: Visa sponsorship is not available for this position. For a continuing position, you must be an Australian or New Zealand citizen or an Australian Permanent Resident.

Australian Temporary Residents currently employed at the University of Sydney may be considered for a fixed term contract for the length of their visa, depending on the requirements of the hiring area and the position.

Pre-employment checks

Your employment is conditional upon the completion of all role required pre-employment or background checks in terms satisfactory to the University. Similarly, your ongoing employment is conditional upon the satisfactory maintenance of all relevant clearances and background check requirements. If you do not meet these conditions, the University may take any necessary step, including the termination of your employment.

EEO statement

The University of Sydney is committed to diversity and social inclusion. Applications from people of culturally and linguistically diverse backgrounds; equity target groups including women, people with disabilities, people who identify as LGBTIQ; and people of Aboriginal and Torres Strait Islander descent, are encouraged.

How to apply

Applications (including a cover letter, CV, and any additional supporting documentation) can be submitted via the Apply button at the top of the page.  

For employees of the University or contingent workers, please login into your Workday account and navigate to the Career icon on your Dashboard.  Click on USYD Find Jobs and apply.

For a confidential discussion about the role, or if you require reasonable adjustment or support filling out this application, please contact Cathy Roll, Recruitment Operations, by email to [email protected]

© The University of Sydney

The University reserves the right not to proceed with any appointment.

Click to view the Position Description for
this role.

Closing Date: 18 October 2021


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