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Biotech
Serve as contact for project teams and investigative sites; conduct and document site contacts; monitor site performance; assist CRAs with visit prep and QC; perform CRF review and query resolution; coordinate study visits, shipments, and supplies; process site invoices and payments; enter data into CTMS; assist regulatory and ethics submissions and translations. Must work with SUVODA and COMET/SAP and be bilingual French/English.
Biotech
Manages country-level clinical trial operations, regulatory submissions, budgets, contracts, payments, local-language materials, timelines, vendors, and site deliverables. Oversees compliance with ICH, GCP, FDA, local regulations, ethics requirements, and study procedures. Coordinates with clinical, regulatory, finance, legal, quality, pharmacovigilance, vendors, investigators, ethics committees, and regulatory authorities. Develops risk mitigation plans, manages local processes and supplies, and supports junior staff. Requires bilingual French-English communication and strong organizational skills.
Biotech
Oversee clinical trial start-up and delivery from site identification through database lock. Manage timelines, budgets, risks, regulatory and ethics submissions, site selection, contracts, supplies, recruitment, monitoring, quality, documentation, and site payments. Lead client communications and collaborate with global cross-functional teams to ensure compliance, patient safety, data integrity, inspection readiness, and successful trial execution.
