Senior Clinical Trial Manager – Hybrid (Melbourne)

About the role

Syneos Health is seeking an experienced Senior Clinical Trial Manager to lead site management, clinical monitoring and central monitoring activities for complex trials. The role is hybrid, based in Melbourne, and focuses on patient safety, regulatory compliance and data integrity.

Key responsibilities

• Oversee site management, clinical and central monitoring deliverables from activation through close‑out, ensuring protocol, GCP and regulatory compliance.
• Identify and mitigate risks using the Risk Assessment and Categorization Tool (RACT) and escalate issues to the Project Manager.
• Coordinate with Study Start‑Up, Patient Recruitment and Data Management to meet activation, enrollment and database lock milestones.
• Develop and maintain clinical study tools, monitoring plans and ensure CTMS, dashboards and other systems are configured and tested.
• Manage resourcing for CRAs and Central Monitors, monitor performance, and ensure quality of monitoring documentation.
• Provide status updates to clients and internal leadership, support inspection readiness and drive corrective action plans.

Required profile

• Bachelor’s degree or RN in a related field, or equivalent education and experience.
• Proven ability to lead cross‑functional teams and deliver project milestones in an international environment.
• Extensive experience in site management and clinical or central monitoring, preferably with risk‑based monitoring.
• Understanding of clinical trial financial principles, budgeting and GCP/ICH guidelines.

Required skills

• Clinical Trial Management System (CTMS) configuration and user acceptance testing.
• Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePRO) platforms.
• IVRS/IWRS, Trial Master File (TMF) management.
• Risk‑based monitoring methodology and development of monitoring plans.
• Good Clinical Practice (GCP) and ICH regulatory knowledge.