Site Activation Specialist (Sponsor-Dedicated) - 0.8 FTE

About the role

Syneos Health is hiring a Site Activation Specialist (sponsor-dedicated, 0.8 FTE) working remotely. The role is responsible for quality deliverables at country level, following project requirements and applicable country rules with minimal oversight from the Site Start-Up Country Manager. It covers submissions, document collection, regulatory approvals and site activation, and may involve vendor management.

Key responsibilities

• Forecast submission and approval timelines, track milestones in the agreed tracking system, analyse delays and propose contingency plans
• Monitor project finances and hours per contract, and escalate discrepancies promptly
• Review SOPs and Work Instructions, keep training records and timesheets compliant, and submit documents to the Trial Master File (TMF)
• Improve quality across Site Start-Up components (submissions, document collection, communication with Competent Authorities and ECs)
• Prepare and submit Central EC, Local EC, RA and other local regulatory or hospital approval submissions, and oversee ongoing submissions, amendments and periodic notifications, including safety notifications
• Support site selection, prepare site-specific contracts and negotiate budgets and contracts with sites and the sponsor
• Act as country-level subject matter expert on start-up and clinical trial regulatory matters, maintain regulatory intelligence on the central repository, and advise on data protection statements
• Provide mentorship to junior team members and may act as Country Delivery Lead, analysing country and site metrics to support first patient in

Required profile

• Bachelor's degree
• Excellent understanding of clinical trials in phases II-IV and ICH GCP
• Good understanding of clinical protocols and study specifications, and of clinical trial start-up processes
• Project management experience in a fast-paced environment
• Ability to mentor, lead and motivate juniors

Required skills

• Vendor management
• Strong organisational skills and ability to handle multiple projects
• Communication, presentation and interpersonal skills
• Quality-driven approach, strong negotiation and problem-solving skills