Senior Clinical Trial Manager (Hybrid, Melbourne based)

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, ensuring compliance with protocol, GCP and regulatory requirements.
• Manage site interactions from activation through closeout, including recruitment, investigator payments and risk mitigation.
• Review study scope, budget and protocol, communicate contractual obligations to the clinical team and flag risks to timeline, quality or budget.
• 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.
• Provide training on protocol specifics, CRF completion, SOPs and monitoring strategies to the study team.
• Monitor project dashboards, CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS and central monitoring dashboards to track site and patient activities.
• Escalate issues, present at key meetings and support inspection readiness.

Required profile

• Bachelor’s degree or RN in a related field, or equivalent experience.
• Proven ability to lead cross‑functional teams and align them to project milestones.
• Experience working in an international, multi‑site clinical environment.
• Strong understanding of clinical trial financial principles, budgeting and risk‑based monitoring.

Required skills

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