Senior Clinical Trials Lead: Governance & Operations (Flex)

Western Sydney; Campbelltown; Hybrid; AUD 121,000 - 134,000; Full time

Benefits offered by this job

Onsite childcare

Health & wellbeing

Staff benefits

Job summary

Western Sydney University’s Faculty of Health seeks a strategic leader to oversee the clinical trials portfolio from start-up to close-out, delivering ethical, timely and budget‑compliant trials from the Campbelltown campus with flexible working arrangements.

You will develop governance frameworks, advise on compliance, oversee budgets and reporting, manage sponsors and CROs, and implement digital and AI-enabled tools to enhance trial operations and data management.

Qualifications

• Relevant tertiary qualifications in health, science, nursing, business administration, research management or a related discipline.
• Extensive clinical trials operations or management experience within a university, health, industry, CRO or research environment.
• Knowledge of ICH-GCP, NHMRC, TGA, ethics, privacy and institutional compliance requirements.
• Experience managing complex clinical trial operations including budgets, timelines, reporting, governance submissions, contracts and stakeholder expectations.
• Strong leadership, communication, analytical and systems skills including CTMS/EDC tools such as REDCap or Medidata.

Responsibilities

• Lead the Faculty’s clinical trials portfolio from start‑up to close‑out within timelines and budget.
• Develop governance frameworks and ensure regulatory compliance and ethical conduct.
• Oversee budgets, forecasting, contracts, reporting and governance submissions.
• Provide specialist advice to investigators, senior stakeholders and external partners.
• Implement digital and AI-enabled tools to improve trial operations and data management.

Skills

Clinical trials

Leadership

Communication

Analytical

CTMS/EDC tools

Education

Relevant tertiary qualifications in health/science or related discipline

Tools

REDCap

Medidata

CTMS

Job description

Western Sydney University’s Faculty of Health seeks a strategic leader to oversee the clinical trials portfolio from start-up to close-out, delivering ethical, timely and budget‑compliant trials from the Campbelltown campus with flexible working arrangements.

You will develop governance frameworks, advise on compliance, oversee budgets and reporting, manage sponsors and CROs, and implement digital and AI-enabled tools to enhance trial operations and data management.