Sponsor Dedicated Site Startup Lead

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Lead, guide, and empower site activation teams across multiple countries • Handle initial, substantial, non-substantial, additional submissions, and member state coordination • Ensure timely collection of submission documents from SSU Specialists across countries • Organize and manage Teams meetings for SSU Specialists • Maintain regular contact with the CRO Lead for CRO-involved countries • Monitor progress, review updates, and maintain oversight of Informed Consent Forms for all EU-CTR countries • Perform QC checks for all site documents on SharePoint and in CTIS • Support the setup of new SSU processes and SOPs; contribute ideas and create training materials and presentations

🎯 Requirements

• Bachelor’s degree in Life Sciences (or international equivalent) • 4+ years of experience in clinical submission processes and optimization and site activation management within a sponsor or CRO environment • Proven experience with country-level ICF creation • Strong proficiency with data models, forecasting tools, and database structures • Experience working in site start-up on a regional level strongly preferred • Ability to explain complex data clearly and support data-driven decision-making • Expert understanding of factors that drive successful study start-up and site selection strategies.

🏖️ Benefits

• Flexible European locations • Stability of a sponsor-dedicated model