[Hiring] Study Start-Up Lead @Fortrea

Role Description

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.

Your Main Responsibilities:

• 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.

Qualifications

• 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

• 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.

Company 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.