Global Study Start-up Lead - Regulatory & CTIS Expert

Clinilabs; Basel; Hybrid; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Clinilabs in Basel, Switzerland seeks a Study Start-up Lead (SSUL) to oversee regulatory submissions for clinical trials globally or regionally, ensuring startup deliverables and timelines. You will provide strategic submission planning and cross-functional coordination, mentoring junior team members while working under regulatory requirements and company SOPs.

The role requires EU CTR/CTIS expertise, strong project leadership, and experience in pharma/biotech/CRO environments.

Qualifikationen

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

Aufgaben

• Regulatory submission and cross-functional leadership.
• Ensure startup activities are on time, within scope and budget per ICH/GCP guidelines.
• Lead strategic aspects of project startup and risk mitigation with proper action plans.
• Coordinate SSU Specialists and ensure training on project systems and procedures.
• Serve as SME for EU CTR and CTIS processes, interpreting regulatory expectations.
• Plan and execute Initial CTAs, Part I & II submissions, Substantial Modifications, and CTIS lifecycle activities for Europe and other regions.
• Oversee RFIs and ensure timely, high-quality responses.
• Support end-of-study activities including EoT notifications and CSR submissions.
• Contribute to SOPs, work instructions and templates.

Kenntnisse

Regulatory leadership

Cross-functional leadership

Project management

Communication skills

Problem solving

Attention to detail

Ausbildung

Bachelor's or Master’s in Life Sciences

Tools

CTIS system

Jobbeschreibung

Clinilabs in Basel, Switzerland seeks a Study Start-up Lead (SSUL) to oversee regulatory submissions for clinical trials globally or regionally, ensuring startup deliverables and timelines. You will provide strategic submission planning and cross-functional coordination, mentoring junior team members while working under regulatory requirements and company SOPs.

The role requires EU CTR/CTIS expertise, strong project leadership, and experience in pharma/biotech/CRO environments.