Brigitte St John Email & Phone Number

North Ryde, Australia

* Run BI reports for Australia & APAC region, and publish on PMED (company database)* Manage departmental CVs in PMED* Back up for Reception* Organise Corporate AMEX applications and cancellations* Assist with monthly Wi-Fi coding and process Telstra payments via KOFAX* Schedule 'Office/Clinical Operations Management' and 'Quarterly All Staff' meetings* Set up meeting rooms, printing, catering and take minutes* Prepare PPT presentation for Quarterly All Staff Meeting* Advise travel group of new starters and departures* Assist and maintain trackers of office equipment for Wi-Fi devices, scanners, cab dockets and laptop bags* Scan, forward and file monthly bank statements

15 Talavera Road, North Ryde

• Track, scan, code, photocopy and file study documents• Support preparation of study-specific documents• Code, process and track invoices• Update and create study personnel in Impact Harmony (IH)• Check RAVE, enter info in IH and request payment breakdowns• Prepare, distribute, store and archive study files• Attend and participate in project, CRA and ROA meetings• Identify inconsistencies and inefficiencies in processes and recommend solutions

4-10 Inman Road, Dee Why Nsw 2000, Australia

* Process and track Serious Adverse Events (SAE)* Process and track of Investigational Medicinal Product (IMP) and study supply shipments to sites, and source and order supplies from vendors* Create study start-up tools and assist with Human Research Ethics Committee (HREC) and/or health authority filing through creation of necessary supportive documentation* Provide assistance to the Country Study Managers in meeting planning and preparation of presentations, meeting materials and minute-taking for local and regional study investigational teams* Track site contract approvals, invoices and payments* Create and maintain contact details of the study team (Asia Pacific) and external site staff, including distribution lists and maintain tracking systems/tools (e.g. CTMS – Clinical Trials Monitoring System)* Assist in the creation and implementation of SOPs* Develop and maintain functional knowledge of GCPs, Roche SOPs, local regulations and therapeutic area(s) through continued training provided by the local Training & Compliance department to ensure patient safety and data integrity* Reconciling/tracking essential documents necessary for the study closure* Track and maintain Study Information and Reports on Study Progress on systems/tools (i.e. CTMS, SAP, Shareweb, Touchpoint, CTP – Clinical Trial Portal) * Participate, as needed, in the development and distribution of Affiliate newsletters for investigators and monitors as needed* Maintain and Manage Appropriate Study Documentation - Trial Master Files (TMF) for the study(s), in accordance with SOP requirements under the direction of LST (Local Study Team)Achievements:* Instrumental in creating SAP manual for Clinical Trial Materials & Drug Despatching* SAP superuser for CTAs requiring assistance with Drug Despatching and Finance Reporting

4-10 Inman Road, Dee Why Nsw 2000, Australia

* General office duties: typing, filing, photocopying, faxing, mail distribution, stationery, archiving, kitchen duties, preparation of slide presentations, laminating, binding, shredding, scanning* Liaise with external study site coordinators, various internal departments and outside suppliers* Assist team of approximately 80 people with: o CRTN requests, changes and update (in Monweb)o CDC document dispatch and reconciliationo Electronic and hard-copy archiving of studies o Attendance and minute-taking at departmental breakfast meetings o Safety information disseminated according to CSM requirements and assist with tracking and filing of SAE reportso Various Ethics submissionso Software and hardware problemso Meetings, teleconferences, workshops, luncheons, booking rooms, and travel arrangementso Local and overseas courierso Arrange car service on behalf of CRA company carso Production of SAP reports and act as back up to CTAs for drug despatcheso Maintenance and update of SAP manualo Check on PIMs (Process Information Management) database that uses a barcode to track patient case report forms (CRF) o Business cards, mobile phones, new starter work-station set-upso Staff welfare celebrationso Maintaining Outlook contacts, medical calendar and distribution listo Set up of new Site/CSM/Pharmacy/Clinical Documentation folders for new study start-upo Invoice coding and check payment against SAP and oversee finance queries

4-10 Inman Road, Dee Why Nsw 2000, Australia

* Organise and set up GMC (Global Monitoring) Course* Arrange and set up ELM (Effective Line Management) Course* Co-ordinate and set up C&T monthly training sessions* Update and maintain training records for all PDOA local and Asia-Pacific region* Update and maintain Compliance & Training source training material/library * Key contact and support for:o PDOA SAP Clinical Trials Materials problemso Shareweb access to Compliance & Training (C&T) areao Access rights to Outlook foldero Creating Purchase Requisitions & Purchase Orders via SAP and sourcing departmental medical supplies & equipment* Responsible for archiving of All PDOA and AP Outlook folders electronically* Update Compliance & Training Calendar for local & AP region* Maintain OFN (Oncology Franchise Network) administration role* Keeping track and organising payment of Ricoh fax machine rentals and organise and track toner supplies for the department as well as study sites* Maintain budget-tracking systems (SAP vs PTS – Payment Tracking System)* Responsible for creating WBS elements/BA Internal Order Numbers

Mlc Centre, Sydney Nsw 2000, Australia

* Responsible for the production and appearance of printed material using PC software (Pagemaker, Corel Draw, Powerpoint, ABC flowchart)* Prepare and set up presentations for high-profile client meetings* Liaise with external and internal customers

Level 16/77 Castlereagh Street, Sydney Nsw 2000, Australia

* Create a high standard of design for the firm's promotional administrative and client-base documentation* Report directly to the Marketing Coordinator and receive work from other areas of the firm including partners, solicitors, support staff and management personnel* Responsible for creating and producing design layouts for newsletters, mail-outs, invitations, forms, report covers, mini-brochures, flyers, advertisements, diagrams, charts (overheads and 35mm slides), manuals, tenders, prospectuses, logos, letterheads, free-hand illustrations, CVs, conference signs, maps, floor plans and scanning* Liaising with suppliers, printers and graphic bureaus* Developed the firm's map logo used frequently on company documentation* Presentation talks to new Summer Clerks on the the best techniques used for their exhibits and presentations* Convert word processing documents from Microsoft word for Windows on PC to DTP software on Macintosh and visa-versa

35/88 Phillip St, Sydney Nsw 2000, Australia

* Responsible for managing the department of six whilst VA Manager away* Running schedules and booking work for the department* Produce high impact graphics for client reports, logos, in-house magazines, book covers, 35mm slides, brochures, forms and invitations* Assist consultants with developing most effective charts and diagrams used for presentations* Assist secretaries and new consultants with software knowledge and skills* Constant overtime and pressure to meet deadlines - flexible and willingness to adjust work hours to meet work demands

Certificate Iv In Assessment & Workplace Training Bsz40198, Training

Diploma In Graphic Design, Graphics

Certificate In Advance Secretarial Studies, Secretarian

Education record