Site Activation Specialist II (Madrid, Hybrid)

About the role

Syneos Health is hiring a Site Activation Specialist II in Madrid under a Functional Service Provider (FSP) arrangement, working in a hybrid model. The role covers quality deliverables at country level, with moderate oversight from the Site Start-Up (SSU) Country Manager, and supports the end-to-end site activation process.

Key responsibilities

• Follow project requirements and applicable country rules, track milestones in the agreed SSU tracking system and escalate delays with a contingency plan
• Monitor basic financial aspects of the project and the number of hours/tasks per contract
• Review and comply with SOPs and Work Instructions, keep training records and timesheets up to date
• Support continuous improvement of quality in SSU components such as submissions, document collection and communication with Competent Authorities and ECs
• Submit documents to the Trial Master File (TMF) and prepare and submit Central EC, Local EC, RA and other regulatory and hospital approval submissions, including safety notifications
• Act as Local Submissions Specialist, liaising with the country start-up advisor (CSA) and SAM, and acting as point of contact for the PM/SAM on allocated projects
• Provide country-level intelligence on start-up and clinical trial regulatory matters, including data protection guidance and input to local SOPs and training materials
• Support site selection, investigator contract and budget negotiations, and quality control of contracts and documents

Required profile

• Bachelor's degree
• Over 2 years of experience on the role
• Detailed understanding of clinical trial start-up processes and of clinical trials across phases II-IV and ICH GCP
• Ability to understand clinical protocols and study specifications
• Ability to manage external vendors and multiple project budgets
• Strong organizational, negotiation, problem-solving and communication skills, able to work independently and in a team