CTA & EU CTR Submissions Lead

Syneos Health, Inc.; Paris; On-site; EUR 65,000 - 95,000; Full time

Job summary

Syneos Health is seeking a Site Activation Manager based in Boulogne-Billancourt to lead regulatory submissions, CTA management, and CTR transitions across EU trials. You will guide cross-functional teams, provide strategic advice on submission planning, and ensure timely completion of activation activities in sponsor-dedicated projects.

The role emphasizes SME-level knowledge of EU CTR submissions, coordination with study teams, and continuous process improvement within a compliant regulatory

Qualifications

• SME on EU CTR submissions and platform use.
• Define CTR transition strategies with stakeholders.
• Lead CTA-specific scientific advice procedures and study teams.

Responsibilities

• Manage a portfolio of CTAs including initial CTAs and maintenance activities.
• Provide advice on submission strategy and country requirements; support regulatory submissions.
• Guide cross-functional teams through CTR processes and provide training on procedures.
• Lead scientific advice procedures for CTA-related activities and manage timelines.
• Monitor milestones and communicate issues to stakeholders as per procedures.
• Support inspection readiness activities as applicable.
• Maintain awareness of regulatory intelligence affecting trials and advise accordingly.

Skills

Regulatory submissions

CTA management

CTR expertise

Cross-functional leadership

Project coordination

Job description

Syneos Health is seeking a Site Activation Manager based in Boulogne-Billancourt to lead regulatory submissions, CTA management, and CTR transitions across EU trials. You will guide cross-functional teams, provide strategic advice on submission planning, and ensure timely completion of activation activities in sponsor-dedicated projects.

The role emphasizes SME-level knowledge of EU CTR submissions, coordination with study teams, and continuous process improvement within a compliant regulatory