Experience

Gallipoli Medical Research Foundation

• Australia
• Research Services
• 1 - 100 Employee

• Ethics, Governance & Quality Manager

  • Jun 2022 - Present

• Senior Ethics & Governance Coordinator

  • Mar 2021 - Jun 2022

• Ethics & Governance Co-ordinator

  • Jul 2019 - Jun 2022



Nucleus Network (formerly Q-Pharm)

• Australia
• Research Services
• 1 - 100 Employee

• QA Officer

  • Jul 2018 - Mar 2019

  Focused on Computer Systems Validation of an electronic Quality Management System (QMS) software application, while providing support for the management of the in-situ system, and other Quality Assurance activities. Focused on Computer Systems Validation of an electronic Quality Management System (QMS) software application, while providing support for the management of the in-situ system, and other Quality Assurance activities.



Nucleus Network (formerly Q-Pharm)

• Australia
• Research Services
• 1 - 100 Employee

• Project Support Officer

  • 2009 - Sep 2016

  • Medical Writing – Protocol/PICF review and editing, writing of PICFs and other patient facing documents and the preparation of ethics and safety submissions to QIMR Berghofer and Bellberry HRECs• Regulatory governance management as required • Provision of expert advice to sponsors regarding ethics submissions• Quality Assurance activities including document review and development, auditing, and QMS software (Q-Pulse) testing, implementation and support, • Staff training (ICH GCP, Ethics submissions, Data Management, Equipment Life Cycle Management, and IT applications)• Equipment Life Cycle Management of Q-Pharm’s clinical equipment Show less

• Clinical Data Manager

  • Jun 2008 - Dec 2011

  Management of the Data Management team, including staff recruitment, training and performance management, and of Data Management activities, including pre-study planning, source/CRF preparation, QC, monitoring, and reporting of clinical trial data via paper based and electronic methods, and archiving. Input into the development of study protocols, and eCRFs (sponsor provided), and assessment and mitigation of study logistics issues.

• QA Officer

  • Aug 2006 - Jun 2008

  Conducted Quality Assurance activities included internal/external auditing, document development and management, improvement activities, archiving, staff training and education, and Quality Management software application (Q-Pulse) testing, implementation and support.



QML Pathology

• Australia
• Hospitals and Health Care
• 400 - 500 Employee

• Acting Clinical Trials Manager

  • Jun 2006 - Aug 2006

  Managed the Clinical Trials Unit through the transitional phase of closing down and migrating studies to an interstate facility. This included staff, client and stakeholder management.

• Senior Project Manager

  • Nov 2002 - Jun 2006

  Project managed nationwide clinical studies from a central laboratory perspective, including provision of service tenders, stakeholder management (sponsors, sites and global affiliates), data management, study specific document development, sample collection, processing and logistics, and laboratory testing. Supported the QML Quality Manager within the Clinical Trials sphere of operation, including internal, client and global sponsor audits, improvement activities, document development and control. Show less

• Shift Coordinator (Endocrinology)

  • Nov 2000 - Nov 2002

  Reviewed, interpreted and released over 200 Endocrinology pathology results to doctors daily, ordered additional testing to be performed when warranted, provided advice to GPs regarding appropriate testing for their patients, supervised scientists and technicians operating automated instruments and performing manual testing, and prepared departmental workload summaries for Management.

• Scientist (Endocrinology)

  • Jul 2000 - Nov 2000

  Performed pathology sample testing using automated instruments (e.g. Centaur, Immulite 2000, AxSYM) and manual methods (RIA, ELISA).