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.

Were now hiring a Study Start-Up Lead to join a sponsordedicated 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 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

• Bachelors 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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