LikeRemoteStart Up Lead - Sponsor-dedicated
from 🇫🇷 France
AtFortrea, 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 aStudy 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 acollaborative, global environment with experts passionate about improving clinical research.
Influencedata-driven study start-up strategies for large-scale international programs.
Play a key role inoptimizing 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 withcountry-level ICF creation.
Strong proficiency withdata models, forecasting tools, and database structures.
Experience working insite start-up on a regional levelstrongly 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 ourEEO & Accommodations request here.