Tim Bower Email & Phone Number

Sydney, New South Wales, Australia

Leading an international team of experts responsible for the strategic capture, verification, reporting and analysis of high quality clinical data and metadata, to support business objectives globally. This includes data for clinical evidence, and data used to track, manage and measure the performance of clinical projects.I provide insight, guidance, strategy and vision for the efficient capture, management, consolidation and use of clinical data, including design and roll-out of data standards, processes, software systems and methods to meet the medium to long term business needs of Cochlear.

Sydney, Australia

Responsible for ensuring that systems and processes for clinical studies globally are optimised to produce efficient, reliable, and effective data and analyses to improve clinical study outputs, improve time to market access and drive an improved customer experience.

Sydney, Australia

Clinical systems development and provision of strategic data management input for a justice health research trial, in collaboration with the Kirby Institute, examining the effect of an intervention to treat impulsivity on recidivism rates in repeat violent offenders.

Sydney, Australia

Management of a headquarters clinical trials technology unit at an innovative Australian ASX200 company.Highlights include:• Reporting, extraction and non-statistical analyses to support regulatory reporting, cross-functional business decisions, trial conduct, metrics, and statistical analyses• Managed stakeholder expectations by convening and facilitating cross-functional meetings, providing formal and informal updates, and fostering an environment of trust and mutual respect• Reviewed clinical trial protocols, providing scientific, operational and data management input with reference to GCP, ICH guidelines, and regulatory, health economics and marketing outcomes• Created key training materials, documentation and SOPs in line with regulatory and operative requirements• Actively engaged technical and non-technical users to ensure continual improvement of systems, processes and data quality• Designed, created, validated, administered and documented web-based data capture devices (EDC eCRFs), clinical trial databases and data validation procedures using Medidata Rave• Championed, implemented and supported a cloud-based randomisation and supply management system (Medidata Balance)• Preparation of patient profiles and dataset defines for an eCTD FDA submission package• Data modelling, mapping, integration and metadata creation for a CDISC compliant legacy data warehouse

Sydney, Australia

Establishment of a clinical trials technology and data management unit at a pioneering Australian ASX200 company.Highlights include:• Creation of an efficient five member unit with a strong team focus and an integral role in the Medical department• Negotiation of key vendor contracts and vendor management• Creation of in-house data standards• Creation of an in-house randomisation and supply management system• First Australian company to bring Medidata Rave, (an industry-specific data management system), in-house, completing a knowledge transfer in record time• Provision of training and training/reference materials for technical and non-technical users, internal and external to the company• Successful start-up and conduct of three multinational Phase III trials, and completion of multiple smaller studies

Sydney, Australia

Systems development for clinical trials within a well established team.Highlights include:• Invited to join the innovation team• Created a timeline prediction tool• Played a key role in improving the efficiency of local specification templates• Development and documentation of clinical trial databases using Oracle Clinical

Sydney, Australia

Managing clinical trial databases with leadership responsibilities.Highlights include:• Presented to functional and site heads as the representative of an international working group• Co-ordinated study management teams• Actively reviewed protocols with suggestions to improve data quality, patient compliance and effective analysis of the primary endpoints• Created training materials for non-technical users• One of the few Study Data Managers to program a study in Oracle Clinical

Sydney, Australia

Event management of a concert to raise awareness, support and money to provide a bursary for a needy student in South Africa. Highlights include:• Management of the event from concept to conclusion• Creation of a steering committee and sub-committees, and co-ordination of planning meetings• Created promotional materials customised for several target audiences• Co-ordination of volunteers, media and distributed materials• Developed a website promoting the cause and event• Exceeded the financial target by 22%

Sydney, Australia

Maintenance of the Australian Data Management Unit in multinational clinical trials.Highlights include:• Training, physical and human resource management• Chaired Data Quality Review Meetings• Wrote and maintained the Standard Operating Procedures and Local Working Instructions for the Data Management, Clinical Research and Information Systems departments• Entry, validation, cleaning and coding of clinical trial data• Assisted in the implementation of new systems• Appointed to the Value Through Innovation Day organising committee

Sydney, Australia

Data management specialist on large international clinical trials.Highlights include:• Trained 20 people in data management processes and Oracle Clinical• Generation of project status reports• Member of the Trials Management System development team• Performed entry, validation and cleaning of clinical trial data• Worked with programming staff to ensure new systems were intuitive, user friendly, and bug free

Bachelor Of Arts, Honours, Psychology

Hsc