Site Activation Specialist II – Hybrid (Sydney)

About the role

Syneos Health is seeking a Site Activation Specialist II to support clinical trial start‑up activities in Australia. The role operates in a hybrid model, combining on‑site presence in Sydney with remote collaboration.

Key responsibilities

• Manage country‑level deliverables, ensuring compliance with project requirements and local regulations.
• Track submission and approval timelines, investigate delays, and support contingency planning.
• Monitor basic financial aspects of projects, escalating discrepancies promptly.
• Prepare and submit central and local ethics committee applications, regulatory authority submissions, and ongoing amendments.
• Act as liaison between investigational sites and functional leads, overseeing end‑to‑end site activation.
• Support site selection, investigator contract negotiation, and budget preparation.

Required profile

• Bachelor’s degree with detailed understanding of clinical trial processes (Phases II‑IV) and ICH GCP.
• Strong organizational and communication skills, able to manage multiple tasks and project budgets.
• Experience working independently and within cross‑functional teams.
• Problem‑solving and negotiation abilities.

Required skills

• ICH Good Clinical Practice (GCP) knowledge.
• Clinical trial start‑up and regulatory submission processes.