Michael Guo Email & Phone Number

Kingsgrove, Nsw, Au

• Employed various skills to define scope, organise budgets, and maintain schedules for various clinical programs and trials. • Determined risks and provided detailed responses to all queries and concerns that were presented by program teams, management personnel, and company stakeholders. • Forecasted program/trial changes, reviewed development, and disseminated information for novel clinical products; all with the aim of monitoring and mitigating risks.

Glebe, Nsw, Au

• Defined scope, collected data, analysed findings, administered research budgets, developed SOPs, negotiated contracts, and ensured confidentiality and safety of all study participants. • Guaranteed data integrity and quality control by developing comprehensive plans, managing lab specimens, and evaluating performance as a Study Coordinator and Manager.• Functioned as a Site/Network Coordinator, Manager, and ASAN Steering Committee; supervised the Australasian Severe Asthma Network (ASAN Network), promoted transparency of information, and consistently liaised with key stakeholders. • Designed and operated a nationwide web-based Australian Xolair Registry (AXR) that detailed patients that have been diagnosed with severe refractory allergic asthma, administered Xolair treatment, and successfully completed the study.• As a Data Custodian, regulated and maintained all systems that were used to collect, manage, and provide ASAN and AXR data.

Sydney, Australia

Dr Guo was a Clinical Research Scientist and the Network Manager for Australasian Severe Asthma Network (ASAN) for over 6 years at Woolcock Institute of Medical Research (WIMR) and prior to WIMR, he worked as the Quality Assurance Officer and Clinical Terminology Analyst for over 4 years at National e-Health Transition Authority (NEHTA). And, prior to NEHTA, he worked as a Data Manager for 2 years at Clinical Trials Centre at National Health & Medical Research Council (NHMRC). Dr Guo practiced as a general surgeon and later as a thoracic surgeon in China before migrated to Australia.

Glebe, Nsw, Au

Sydney, New South Wales, Australia

• Developed and improved various protocols and policies that were aimed at driving the accurate evaluation of processes, maintenance of SOPs, and support during the review of all internal documents. • Drove the integration of eHealth into clinical practices throughout Australia by implementing various eHealth standards, designing electronic health records, and applying several clinical terminologies. • Successfully developed the first version of the standard clinical terminology for e-health solutions (Australian Medicines Terminology - ACOM), which were later nominally changed to the Australian Medicine Terminology (AMT) and summarized in eDiagnostics (Radiology and Pathology), eDischarge Summaries, eReferral, and eMedication Management in Australia.

Sydney, New South Wales, Australia

• Developed and implemented policies, executed data handling procedures, and formulating techniques that were aimed at improving the adequacy, accuracy, and legitimacy of all collected data. • Supported the daily use of all data systems (that monitor and track forms, tools, and templates) by managing processes, supporting the workflow of clinical trial sites, and ensuring compliance of all site protocols as a Site/Clinical Monitor. • Trained new and existing site personnel on accurate steps to perform various tasks during all phases of the clinical trial.• Aided in the smooth execution of tasks that were performed during the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study.• Troubleshot data-related problems after discovering and resolving issues related to regulatory affairs.