Senior Site Navigator - FSO

Fortrea; Paris; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Fortrea is seeking an experienced clinical operations professional for the Senior Site Navigator role, focused on start-up activities and in-house CRA responsibilities. You will own key processes in a global CRO environment, lead site outreach, feasibility, and regulatory submissions, and drive site activation from initiation through closure.

Ideal candidates have a life sciences degree with 3+ years in start-up, strong EC/RA submission experience, contract negotiations, and excellent ICH/GCP

Qualifications

• University degree in life sciences or related field.
• Minimum 3+ years of experience in start-up activities for clinical trials.
• Hands-on start-up experience and EC/RA submissions knowledge.
• Proven experience in regulatory documentation and approvals.
• Strong contract and budget negotiation skills.
• Excellent knowledge of ICH/GCP and clinical trial processes.

Responsabilités

• Manage site identification, feasibility and full start-up activities, including site outreach and confidentiality agreements.
• Lead Ethics Committee and Regulatory Authority submissions and amendments.
• Drive and track regulatory documents to ensure timely site activation.
• Act as primary contact for investigative sites during start-up and early study phases.
• Negotiate contracts and budgets with internal stakeholders.
• Perform Pre-Study Visits and support Site Initiation Visit preparation.
• Conduct in-house CRA tasks: document review, CRF review, data validation, remote monitoring.
• Ensure TMF completeness and inspection readiness.

Connaissances

Start-up expertise

Regulatory submissions

Contract & budget negotiations

ICH/GCP knowledge

Organizational skills

Proactive communication

Cross-functional collaboration

Formation

University degree in Life Sciences

Description du poste

Fortrea is looking for an experienced clinical operations professional to join our team as Senior Site Navigator, with a strong focus on clinical trial start‑up activities and in-house CRA responsibilities. This role is ideal for someone with solid start‑up expertise who is ready to take ownership of key processes within a global CRO environment.Key responsibilitiesManage site identification, feasibility, and full start‑up activities, including site outreach, feasibility questionnaires, and confidentiality agreementsLead and coordinate Ethics Committee and Regulatory Authority submissions, including initial submissions and amendmentsDrive and track essential regulatory documents to ensure timely and compliant site activationAct as primary point of contact for investigative sites during start‑up and early study phasesIndependently manage site contract and budget negotiations in collaboration with internal stakeholdersPerform remote Pre‑Study Visits and support Site Initiation Visit preparationConduct in‑house CRA activities such as document review, CRF review, data validation, and remote monitoring tasksEnsure TMF completeness and inspection readinessCollaborate closely with CRAs, project teams, and cross‑functional stakeholders to meet study timelinesQualificationsUniversity degree (life sciences preferred)Minimum 3+ years of experience in Start‑UpStrong hands-on experience in clinical trial start‑up is essentialProven experience with EC/RA submissions and regulatory documentationSolid experience in contract and budget negotiationsGood knowledge of ICH/GCP and clinical trial processesStrong organizational skills, attention to detail, and proactive communicationAbility to manage multiple priorities independently in a structured wayLearn more about our EEO & Accommodations request here .