Senior Site Navigator
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Key responsibilities
Manage 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 .
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