Experteer Overview
In this role you drive end-to-end site activation within Madrid, ensuring regulatory submissions, essential document handling, and compliance with country rules. You collaborate with country start-up leadership and cross-functional teams to deliver timely, quality submissions and site onboarding. You will manage start-up processes, liaise with investigators, and support continuous improvement of SSU activities. This position offers impact across trials and regulatory environments, within a mission-driven organization that values delivering patient progress.
Compensaciones / Ventajas
• Oversee end-to-end site activation at country/site level, ensuring timelines and quality deliverables
• Monitor and report on submission milestones and regulatory filings, with contingency planning for delays
• Ensure SOPs/WIs are followed and training records kept up to date
• Support local and central EC/RA submissions and notifications to regulatory authorities
• Coordinate with PM/SAM and investigators, acting as liaison for start-up tasks and documentation
• Review and prepare essential document packages for site activation and TMF archival
• Assist country CSA/SAM in start-up intelligence and regulatory compliance information management
• Support site contracts, budgets, and negotiations with sites where applicable
• Maintain site performance metrics and contribute to continuous improvement of SSU components
Responsabilidades
• Bachelor's Degree
• u003e2 years of experience in site activation/start-up or related clinical operations role
• Understanding of clinical trial processes across Phases II–IV and ICH GCP
• Ability to manage external vendors and negotiate contracts
• Strong organizational, written and verbal communication skills
• Ability to manage multiple budgets and projects with increasing complexity
• Problem-solving, independent work style, and team collaboration
Requisitos principales
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📌 Site Activation Specialist II. Location in Madrid. FSP. Hybrid model.
🏢 Syneos Health
📍 Madrid
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