EU CTR Study Start-Up Specialist

ICON Strategic Solutions; Paris; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are seeking a Clinical Trial Associate in Study Start-Up to support regulatory submissions and activation activities across studies under EU CTR.

You will work with Study Start-Up Managers and cross-functional stakeholders to ensure timely preparation and activation of trials. Your profile should include a Bachelor’s degree in a scientific or healthcare field, CRO/industry Start-Up experience, and strong

Qualifications

• Bachelor's degree in a scientific or healthcare-related field.
• Experience supporting Study Start-Up activities within a CRO, pharmaceutical company or clinical research environment.
• Knowledge of clinical trial processes, regulations, and guidelines.
• Knowledge of European Clinical Trial Regulation (EU CTR) processes.
• Excellent organizational and communication skills.
• Ability to work collaboratively in a fast-paced environment with attention to detail.
• Willingness to travel as required (approximately 10%)

Responsabilités

• Support the preparation and coordination of EU CTR submission packages for initial applications and substantial amendments.
• Coordinate submission timelines and track milestones to ensure timely study start-up execution.
• Collaborate with local study teams, Study Start-Up Managers, Medical Advisors and other stakeholders to ensure country readiness before submission.
• Manage interactions with external translation vendors and coordinate document translation activities.
• Support management of Requests for Information (RFIs), including timeline tracking, response coordination and follow-up with internal stakeholders.
• Support the coordination of Investigational Medicinal Product (IMP) supply activities during study start-up.
• Support French-specific regulatory declarations and notifications with relevant authorities and healthcare professionals when required

Connaissances

Organizational skills

Communication skills

Team collaboration

Attention to detail

Formation

Bachelor's degree in a scientific or healthcare-related field

Description du poste

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are seeking a Clinical Trial Associate in Study Start-Up to support regulatory submissions and activation activities across studies under EU CTR.

You will work with Study Start-Up Managers and cross-functional stakeholders to ensure timely preparation and activation of trials. Your profile should include a Bachelor’s degree in a scientific or healthcare field, CRO/industry Start-Up experience, and strong