Sydney Hybrid Site Activation Specialist II

Syneos Health, Inc.; Sydney; Hybrid; AUD 90,000 - 120,000; Full time

Job summary

Syneos Health is seeking a Site Activation Specialist II based in Sydney with a hybrid work model. You will lead country-level Site Start-Up activities, ensure timely regulatory submissions, and collaborate with clinical teams to activate sites.

You will monitor project timelines, budgets, and quality standards, while ensuring SOPs are followed and documents are properly filed. Experience in regulatory processes and vendor coordination is essential for success.

Qualifications

• Bachelor’s Degree.
• Knowledge of clinical trial processes across Phases II–IV and ICH GCP.
• Ability to manage external vendors to contract effectively.
• Strong organizational, written and verbal communication and interpersonal skills.
• Ability to manage multiple budgets with increasing complexity.
• Quality-driven with negotiation and problem-solving skills; able to work independently or in a team.

Responsibilities

• Own country-level quality deliverables within forecasted timelines and track milestones.
• Monitor financial aspects and hours/tasks per contract; escalate discrepancies.
• Ensure SOPs/WIs are followed and training records updated; ensure timesheet compliance.
• Support improvements in Site Start-Up components and document submissions to TMF.
• Prepare and submit EC/RA applications and other regulatory submissions as required.
• Coordinate with investigators and cross-functional leads; supervise end-to-end site activation.

Education

Bachelor’s Degree

Understanding of clinical trial processes

Vendor management

Organizational skills

Written & verbal communication

Negotiation

Problem-solving

Independent and team work

Job description

Syneos Health is seeking a Site Activation Specialist II based in Sydney with a hybrid work model. You will lead country-level Site Start-Up activities, ensure timely regulatory submissions, and collaborate with clinical teams to activate sites.

You will monitor project timelines, budgets, and quality standards, while ensuring SOPs are followed and documents are properly filed. Experience in regulatory processes and vendor coordination is essential for success.