Global Site Activation Lead — Clinical Start-Up

Syneos Health; Sydney; Hybrid; AUD 90,000 - 130,000; Full time

Job summary

Syneos Health is seeking a Site Activation Specialist II in Sydney with hybrid work arrangement. You will manage in-country site start-up activities, coordinate regulatory submissions, and align with country start-up advisors to ensure timely, compliant delivery across projects spanning clinical trial phases.

The role requires a strong understanding of GCP/ICH, excellent coordination skills, and the ability to navigate complex regulatory environments while maintaining high-quality documentation

Qualifications

• Bachelor's degree or equivalent in life sciences or related field.
• Strong understanding of clinical trial start-up processes and regulatory requirements.
• Excellent organizational, time management and multitasking abilities.
• Clear written and verbal communication; ability to work with diverse stakeholders.
• Experience managing budgets and tracking hours across contracts.
• Detail-oriented with quality-driven approach; capable of independent work and collaboration.

Responsibilities

• Oversee site activation processes in country, ensuring compliance with timelines and SOPs.
• Coordinate submissions to EC/RA and other regulatory bodies; manage essential document collection.
• Collaborate with PM/SAM and country start-up advisor; provide status updates and contingency planning.
• Monitor project milestones, timesheets, and budget usage; escalate variances promptly.
• Ensure documentation is filed in TMF per sponsor requirements and company SOPs.

Job description

Syneos Health is seeking a Site Activation Specialist II in Sydney with hybrid work arrangement. You will manage in-country site start-up activities, coordinate regulatory submissions, and align with country start-up advisors to ensure timely, compliant delivery across projects spanning clinical trial phases.

The role requires a strong understanding of GCP/ICH, excellent coordination skills, and the ability to navigate complex regulatory environments while maintaining high-quality documentation