Clinical Trials Quality Control Manager

**Acknowledgement of Country**:
CSIRO acknowledges the Traditional Owners of the land, sea and waters, of the area that we live and work on across Australia. We acknowledge their continuing connection to their culture and pay our respects to their Elders past and present. View our vision towards reconciliation

**The Opportunity**:

- **Develop the Quality Management Strategy for the Unit and implement the quality management system**:

- **Join CSIRO A truly collaborative, flexible and inclusive workplace**

CSIRO’s Health & Biosecurity business unit is dedicated to conducting scientific research that delivers innovation to Australia's food, health, medical and wellness industries, resulting in significant health and economic benefits for Australians. We're working to prevent illnesses, develop a better understanding of diseases, and improve detection, treatment, and recovery in a range of medical conditions to help people live healthier lives. The Human Health research program aims to expand our national and global impact by delivering R&D that drives a shift toward improved preparedness against human health threats, and enhanced quality of life for all Australians across their lifespan.

The CSIRO Clinical Trials Unit (CTU) is an important capability within the Human Health Program that aims to improve health, wellbeing, and resilience against chronic, infectious and vector-bone diseases for Australians. The CTU has a strong reputation for delivering high-quality clinical trials, traditionally in nutrition and health studies and are now expanding to a broader range of health and wellness market sectors. The CTU operates out of two vibrant health and medical precincts located at the South Australian Health & Medical Research Institute (SAHMRI) in Adelaide and a sister clinic within the Westmead Health and Medical Research Precinct, Sydney.

Reporting to the Human Health Deputy Program Director, the Clinical Trial Quality Manager will work closely with the CTU to develop, implement and manage a comprehensive Quality Management Strategy (QMS) for the CTU, aligned to the National Clinical Trial Governance Framework under the Australian Health Service Safety and Quality Accreditation Scheme (AHSSQA).

CSIRO is committed to providing learning and development opportunities to accelerate professional development and build skills to enable CSIRO to tackle the greatest challenges. In this role you will be supported to build your skills and expertise, and we encourage emerging leaders within the Clinical Trials field with some working experience in quality management to apply.

**Your duties will include**:

- Implement and manage a clinical quality management system for Phase II to IV clinical trials.
- Establish a training curriculum related to GCP systems/processes, including development of training materials, delivering, and documenting training compliance.
- Drive system and process improvement initiatives and develop and maintain appropriate tools and standard operating procedures to further enhance quality management activities.
- Plan, manage, perform and report regular quality reviews for clinical trials and document internal systems and processes, in order to ensure compliance with regulatory requirements, ethics committees and CSIRO policies and procedures.
- Lead and/or participate in the planning, conduct, follow-up and resolution of issues identified from Regulatory GCP inspections and sponsor audits.
- Manage relevant vendor selection and performance.
- Maintain current industry knowledge of applicable regulations, guidelines, and standards.
- Travel to CSIRO Clinical Trial sites in Adelaide and Sydney will be required.

**Location**: Adelaide SA (preferable), or Sydney NSW, Canberra ACT, Clayton/Geelong Victoria

**Salary**: AU$117k - AU$138k plus up to 15.4% superannuation

**Tenure**: Indefinite

**Reference**: 87262

**To be considered you will need**:

- Bachelor’s degree or equivalent work experience in a discipline relevant to clinical trials and some working exposure to clinical trial quality management.
- Working knowledge of national and international regulations, guidelines and best practice related to the conduct of Phase II, III and IV clinical trials.
- Strong computer literacy with knowledge of clinical trials software and MS Office suite.
- An in-depth understanding of the clinical trials processes.
- Previous experience of working in R&D, Pharmaceutical or Commercial Research Organisation (CRO) environments is desirable, as is experience in the training of clinical trial staff.

For full details about this role please view the **Position Description**

**Eligibility**:
Applications for this position are open to Australian Citizens, New Zealand Citizens and Australian Permanent Residents only.

**Flexible Working Arrangements**:
We work flexibly at CSIRO, offering a range of options for how, when and where you work.

**Diversity and Inclusion**:
We are working hard to recruit peo