Global Clinical Start-Up Lead, EU CTR/CTIS Expert

Clinilabs; Allschwil; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Clinilabs seeks an experienced Study Start-up Lead (SSUL) to oversee global regulatory submissions for clinical trials, ensuring timely, compliant start-up activities across NA and ROW. The role combines strategic submission planning with cross-functional coordination and SME input, mentoring junior staff without direct line management.

Reporting to the Global Feasibility, Regulatory and Start-up Head, the SSUL will guide initial CTAs, EU CTR submissions, and CTIS lifecycle activities while

Qualifikationen

• Bachelor’s or master’s degree in Life Sciences or related field.
• 3+ years’ experience in global regulatory environment with EU CTR submissions and CTIS expertise.
• Strong understanding of EU CTR timelines, dossier content, and results of reporting.
• Proven ability to lead complex submission programs.
• Excellent communication, prioritization, and problem-solving skills.

Aufgaben

• Regulatory submission and cross-functional leadership.
• Ensure startup activities for projects are on time, within scope and budget, compliant with ICH/GCP and SOPs.
• Lead project plans for startup, coordinating SSU Specialists and ensuring proper training.

Kenntnisse

Regulatory leadership

EU CTR submissions

CTIS expertise

Cross-functional leadership

Regulatory strategy

Project coordination

Communication skills

Problem-solving

Ausbildung

Bachelor’s or Master’s degree in Life Sciences

Tools

CTIS system

Jobbeschreibung

Clinilabs seeks an experienced Study Start-up Lead (SSUL) to oversee global regulatory submissions for clinical trials, ensuring timely, compliant start-up activities across NA and ROW. The role combines strategic submission planning with cross-functional coordination and SME input, mentoring junior staff without direct line management.

Reporting to the Global Feasibility, Regulatory and Start-up Head, the SSUL will guide initial CTAs, EU CTR submissions, and CTIS lifecycle activities while