Start Up Lead - Sponsor-dedicated

Job description

At Fortrea , we believe in improving lives through the power of science, collaboration, and innovation. As a global CRO partner, we support mission-driven sponsors in bringing new therapies to the patients who need them. We’re now hiring a Study Start-Up Lead to join a sponsor‑dedicated team and drive the successful planning and activation of clinical trials. If you are passionate about accelerating study timelines, using data to guide decisions, and mentoring study start-up teams — this role offers you the opportunity to create a real impact. Why join Fortrea? Work in a collaborative, global environment with experts passionate about improving clinical research. Influence data-driven study start-up strategies for large-scale international programs. Play a key role in optimizing processes , bringing fresh ideas, and driving continuous improvement. Benefit from flexible European locations and the stability of a sponsor-dedicated model. Your Main Responsibilities In this role, you will lead, guide, and empower site activation teams across multiple countries. In that respect, your main responsibilities will be as follows: EU-CTR Submission Management: Handle initial, substantial, non-substantial, additional submissions, and member state coordination. Document Oversight: Ensure timely collection of submission documents from SSU Specialists across countries. Meeting Coordination: Organize and manage Teams meetings for SSU Specialists. CRO Collaboration: For CRO-involved countries, maintain regular contact with the CRO Lead, assist with issue resolution, address questions from CRO Specialists, and connect them with Clinical Operations. ICF Management: Monitor progress, review updates, and maintain oversight of Informed Consent Forms for all EU-CTR countries. Quality Control: Perform QC checks for all site documents on SharePoint and in CTIS. Process Development: Support the setup of new SSU processes and SOPs; contribute ideas and create training materials and presentations. What You Bring 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. Ready to make an impact? Join Fortrea and play a key role in bringing new therapies to patients faster. Apply today and help shape the future of clinical research. Learn more about our EEO & Accommodations request here .