• Performing start-up, initiation, monitoring and close-out visits along with maintaining appropriate documentation• Developing skills and knowledge on clinical trials within a broad scope of therapeutic areas• Monitoring all aspects of studies to ensure compliance with GCP, study protocol and regulatory requirements and prepare monitoring reports• Development and review study protocols and other study-related documents• Preparing ethics submissions and assist in the preparation of Clinical Study Reports

• Carried out the role of Program Manager leading newly created clinical trials team• Liaised with cross-functional internal teams to develop internal and external branding and gauge local and regional research, development, training and support requirements• Performed secretarial duties for NSW Regional Health Partners (NSWRHP) Clinical Trials Advisory Committee (CTAC)• Responsible for the preparation, organisation, and administration of meetings• Carried out membership communication• Developed long-lasting relationships with external partners

• Acted in the role of CRA for Phase II Depression double-blind plus extension studies in start-up• Responsible for eTMF uploading and management• Collected essential documentation• Oversaw site management for 12 sites across Australia, New Zealand, and Singapore

• Carried out CTA role for assorted trials for sponsor clinical department• Responsible for eTMF uploading and management• Collected essential documentation• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaised with vendors

• Conducted Remote Monitoring for two ongoing studies for all sites globally: Rheumatoid Arthritis and Crohn’s Disease• Ensured procedures were in place for the appropriate optimisation of patients into the clinical trial • Monitored the assigned clinical trials following company SOPs and per GCP and maintained project files

• Responsible for Study start-up for NZ HDEC ethics submissions and ongoing reporting, regulatory document collection and studied budget reviews and negotiations• Conducted site visits and management• Carried out initiation visits, on-site and remote monitoring and trial management• Responsible for mentoring and training of MRINZ personnel• Managed the central monitoring team, study coordinators, monitoring staff, and MRINZ research fellows • Attended co-monitoring visits with junior monitoring staff

• Managed the Setup, monitoring and site management for the following studies: Melanoma study – 5 NZ sites; 23 patients enrolled with 10 randomised to treatment, DVT recurrence prevention – 6 NZ sites; 62 patients enrolled and randomised (NZ target: 30), Crohn’s Disease study – 4 NZ sites; 4 sites initiated• Presented study protocol to hospital-based teams of 6-40 participants at initiation visits for 9 sites across two studies• Managed and mentored hospital-based research staff • Liaised with site staff for collection of regulatory documents

• In-sourced to Novartis pharmaceuticals• Managed start-up specialist for Phase I-III oncology studies• Negotiated clinical trial budgets and clinical trial research agreements (CTRAs) • Liaised with specialist physicians, nursing unit managers, study coordinators, pharmacists, and other allied health staff• Prepared local and national ethics submissions for Australian & New Zealand hospital-based clinical trial teams • Liaised with staff for collection of regulatory documents and maintained SharePoint central study file repository and eTMF

• Managed study site start-up SCRA for Phase III/IV diabetes study• Prepared local and national ethics submissions for 20 Australian & New Zealand sites• Reviewed and negotiated clinical trial budgets• Liaised with site staff for collection of regulatory documents• Maintained SharePoint central study file repository and eTMF

• Provided project management training, application access and ongoing support and coaching of CSU staff from• Carried out Timesheet recording (Actime) + extraction and data reporting via Excel• Liaised with head office teams as a beta tester for training modules • Participated in global focus groups for system improvement• Attended quarterly web-based training meetings with a global network of Systems Experts • Connected with local and global IT groups for resolution of technical issues• Utilised NetMeeting and Adobe Web Connect for virtual meetings to train and support regional staff in Australia and NZ• Coordinated equipment provisioning for department staff and hospital site staff as required