Job Description

The Senior Site Navigator is responsible for coordinating and delivering site-level start-up activities for clinical studies, acting as the primary point of contact for investigative sites throughout the study The role ensures timely site activation, regulatory compliance, and effective collaboration between sponsors, CRO teams, and clinical sites. As a senior team member, this position operates with limited oversight and serves as a local country or regional expert.

Key Responsibilities

• Lead site start-up activities from feasibility through site activation, ensuring compliance with ICH/GCP, local regulations, SOPs, and project requirements
• Identify, assess, and engage investigative sites, including feasibility, pre-study visits, and essential document collection
• Manage regulatory submissions, site contracts and budgets, and ongoing site compliance in collaboration with internal stakeholders
• Serve as the primary point of contact for assigned sites, proactively managing risks and supporting study timelines
• Ensure accurate documentation, system compliance, and audit readiness, including TMF maintenance

Requirements & Experience

• Degree in life sciences or allied health discipline, or equivalent clinical research experience
• Minimum 3 years’ experience in clinical research, study start-up, or regulatory processes
• Strong working knowledge of ICH/GCP, regulatory authority and IRB/IEC requirements
• Experience with site contract and budget negotiations and cross-functional collaboration
• Fluency in English and Czech, written and verbal

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