Start Up Lead - Sponsor-dedicated

Fortrea; Paris; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Fortrea, a global CRO, is hiring a Study Start-Up Lead to drive planning and activation of clinical trials across Europe. You will mentor SSU teams, optimize submission processes, and shape study start-up strategies to accelerate timelines.

In this role, you will manage EU-CTR submissions, coordinate with SSU Specialists, oversee ICF creation, and ensure quality control across CTIS and SharePoint, delivering timely study activation while promoting data-driven decisions.

Qualifications

• Bachelor’s degree in Life Sciences or international equivalent.
• 4+ years in clinical submission processes and site activation within sponsor/CRO.
• Proven experience with country-level ICF creation.
• Strong data modeling, forecasting, and database skills; regional site start-up experience preferred.

Responsabilités

• EU-CTR submission management and country coordination.
• Ensure timely collection of submission documents from SSU Specialists.
• Organize and manage Teams meetings for SSU Specialists.
• Coordinate with CRO Lead; assist with CRO issues and questions.
• Monitor progress and oversee Informed Consent Forms for EU-CTR countries.
• Perform QC checks for site documents on SharePoint and CTIS.
• Support new SSU processes, SOPs, and training materials.

Connaissances

Clinical submission processes

Site activation management

Data models

Forecasting tools

Database structures

ICF creation

Regional site start-up

Formation

Bachelor's degree in Life Sciences

Outils

CTIS

SharePoint

Teams

Description du poste

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

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.

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.

Learn more about our EEO & Accommodations request here.