Global Study Start-Up Lead – Data-Driven Trials

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

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.