Senior Site Navigator - FSO
On-siteParis, Île-de-France, France
Job Summary
Manage site identification, feasibility, and full start-up activities, including site outreach, feasibility questionnaires, and confidentiality agreements. Lead and coordinate Ethics Committee and Regulatory Authority submissions, drive essential regulatory documents to ensure timely site activation, and act as the primary point of contact for investigative sites during early study phases. Independently manage site contract and budget negotiations, conduct remote Pre-Study Visits, and perform in-house CRA activities such as document review, CRF review, and data validation. Ensure TMF completeness and inspection readiness while collaborating with CRAs and cross-functional stakeholders to meet study timelines. This role requires a minimum of 3+ years of start-up experience and strong knowledge of ICH/GCP.
Required Qualifications
- University degree (life sciences preferred)
- Minimum 3+ years of experience in Start‐Up
- Strong hands-on experience in clinical trial start‐up is essential
- Proven experience with EC/RA submissions and regulatory documentation
- Solid experience in contract and budget negotiations
- Good knowledge of ICH/GCP and clinical trial processes
- Strong organizational skills, attention to detail, and proactive communication
- Ability to manage multiple priorities independently in a structured way
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