Lead and empower site activation teams to drive the successful planning and activation of clinical trials across multiple countries. Manage EU-CTR submissions, oversee document collection, and optimize study start-up processes and SOPs.
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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