Start Up Lead - Sponsor-Dedicated

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](https://careers.fortrea.com/us/en/eeo-and-accommodations).