Regional Clinical Study Leader

BeiGene, Ltd.; Basel; Remote; AUD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Performance-based bonus

Company shares

Learning & development opportunities

Comprehensive benefits

Zusammenfassung

BeOne seeks a Regional Clinical Operations Lead to drive regional study delivery with inspection readiness and adherence to timelines and budgets. You will lead the regional operations team, oversee external partners, and coordinate with CST and senior management to ensure study success across the region.

You will manage feasibility input, site selection, regulatory submissions, and TMF quality while ensuring compliance with ICH/GCP guidelines and global study plans.

Qualifikationen

• Bachelor’s Degree in a scientific or healthcare discipline required, Higher Degree preferred.
• 4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry.
• Proven experience in clinical research including relevant experience as team lead in clinical functions.
• Experience as CRA is preferred.

Aufgaben

• Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study.
• Leads external vendors involved in study delivery on a regional level and collaborates with key stakeholders in the region.
• Represents the regional study team at CST meetings and internal cross-functional reviews.
• Ensures regional and country regulatory submissions and timely updates in study systems.
• Monitors study activities to ensure compliance with protocol, SOPs and regulatory requirements.

Jobbeschreibung

BeOne seeks a Regional Clinical Operations Lead to drive regional study delivery with inspection readiness and adherence to timelines and budgets. You will lead the regional operations team, oversee external partners, and coordinate with CST and senior management to ensure study success across the region.

You will manage feasibility input, site selection, regulatory submissions, and TMF quality while ensuring compliance with ICH/GCP guidelines and global study plans.