About this role
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.
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