Playing a crucial role in ensuring the efficient and accurate management of research data throughout the study lifecycle. This includes a key role in the planning, implementation, and management of data and data management systems. Responsibilities encompass overseeing the design of SaaS solutions and databases, ensuring data accuracy and completeness, and collaborating with cross-functional teams to meet project goals. Achieving goals with an exceptionally strong background in research data management, being detail-oriented, and having a thorough understanding of regulatory requirements. Operating in a hybrid/remote flexible fashion and supporting the global Pacific Edge team in international projects of several years' duration. Tasked with building an appropriately sized research data management team to complement and support Pacific Edge’s ongoing and future projects.

Playing a crucial role in ensuring the efficient and accurate management of clinical trial data throughout the study lifecycle. This includes a key role in the planning, implementation, and management of data and data management systems. Responsibilities encompass overseeing the design of SaaS solutions and databases, ensuring data accuracy and completeness, and collaborating with cross-functional teams to meet project goals. Achieving goals with an exceptionally strong background in clinical data management, being detail-oriented, and having a thorough understanding of regulatory requirements. Operating in a hybrid/remote flexible fashion and supporting the global Pacific Edge team in international projects of several years' duration. Tasked with building an appropriately sized Clinical Data Management team to complement and support Pacific Edge’s ongoing and future clinical trials.

• Resident Director for foreign-invested subsidiaries in various industries• Specialises in providing high-level advice to Boards on best practice corporate governance, and guiding Boards and shareholder investors through Australian compliance requirements• Acts as the shareholder’s representative to ensure adherence with compliance protocols, and safeguarding against executive mismanagement and misconduct• Provides strategic advice as required on clients’ business plans and Australian projects, and troubleshooting on other relevant areas of their business

Experienced and accomplished consultant, managing all aspects of Clinical Data Management activities across global and regional clinical trials. Consulting services for Pharmaceutical, Biotechnology, and Clinical Research Organizations (CRO) across a broad range of therapeutic areas as well as different study Phases.Leveraging over 22 years of CRO and Pharmaceutical experience, Ӕ3 Consulting helps organizations address a multitude of Clinical Data Management challenges and at the same time develop mutually agreeable and workable solutions.Consulting services include but are not limited to: Study management.Database design management.EDC system evaluation, selection and vendor negotiations and management.MedDRA & WHODrug Coding Dictionaries, licensing and costing advice as well as vendor negotiations and management.Working at all levels to ensure positive outcomes.Providing guidance, motivation, and leadership.Adaptive and customized service to suit Sponsor needs.Start-up, Conduct and Close-out study Phases – Consult, Review & Approve.• CRF Design, Edit Check Specifications and Database Set-up & Design• Full or Partial UAT of Database and Edit Checks• Data Management Plan, External Data Transfer Plans, Data Review Plan, eCRF Completion Guidelines, etc.• Data cleaning and query generation review – EDC and manual checks • Ensure CRO provides ongoing data cleaning and locking of cohorts and/or study parts (e.g., SAD, MAD) (if required)• Clinical Coding of AE, CM & MH data – Timely, Consistency and Accuracy• External Data Reconciliation and Cleaning – LABs, PK, etc.• SAE Reconciliation• Final Data Cleaning• Database Lock on time

Assigned various tasks to evaluate, address, and manage areas within the Biometrics department. Collecting and analyzing information to optimize efficiencies, processes and quality. Taking appropriate and effective corrective and/or preventive action to prevent issues. Verifying and validating corrective and preventive actions and communicating this to senior management and relevant staff members. Documenting activities to ensure dealing effectively and preventing future problems.

Reporting to the COO. To provide strategic leadership to the Biometrics Department by developing employees to their full potential whilst maintaining profitability and a competitive advantage with increased productivity through streamlined processes and exceptional financial management.Accomplishments: Growing FTEs from 200 to 290 and maintain favourable Gross Margins. Expanding the Biometrics team to Taiwan through integrating the PPC Group (acquired by Novotech). Managed employee turnover rate below 10%. Reached board approved budget year on year.

Reporting to the CEO. To grow the department, develop employees and attract key talent for the future whilst expanding business through leading and assisting with negotiations, departmental budgeting and putting efficient workflows in place to maximise the department’s productivity.Accomplishments: Growing FTEs from 16 to 200 and maintain favourable Gross Margins. Expanding the Biometrics team in Australia by successfully integrating CNS (Clinical Network Services) after Novotech acquisition. Effectively fine-tuned economies of scale with the rapidly growing department by means of evaluating and changing processes where and when needed.