Site Activation Specialist (US Experience)

About the role

Syneos Health is seeking a Site Activation Specialist with US experience to support clinical trial start‑up activities at the country level. The role ensures compliance with project timelines, regulatory requirements, and internal SOPs while coordinating with site investigators and functional leads.

Key responsibilities

• Track and report milestone progress in the SSU tracking system, providing rationale for any delays and supporting contingency planning.
• Prepare and submit Central and Local Ethics Committee (EC) applications, regulatory authority submissions, and ongoing amendments, ensuring all documents are uploaded to the Trial Master File.
• Support site selection and feasibility activities, collaborating with the Site Selection Lead and Project Manager.
• Assist with local investigator contract and budget negotiations, preparing site‑specific contracts and ensuring proper execution and archiving.

Required profile

• Experience in clinical trial start‑up processes, particularly within the United States.
• Strong understanding of regulatory and ethics submission requirements.
• Ability to monitor project financials and manage documentation compliance.

Required skills

• Knowledge of trial master file (TMF) requirements.
• Familiarity with ethics committee (EC) and regulatory authority submission processes.