Experteer Overview
In this role you lead regional study delivery within time and budget constraints, ensuring inspection readiness and alignment with global study goals. You manage the regional clinical operations team and external partners, driving cross-functional collaboration and timely updates to senior management. You oversee feasibility, site selection, regulatory submissions, data capture, and quality assurance to deliver high-quality study outcomes. This position offers impact through regional leadership in cancer-focused clinical research and close collaboration with integral teams. You will shape regional execution and continuous improvement in a fast-paced, mission-driven environment.

Compensaciones / Incentivos
• Lead regional study delivery with inspection-ready quality within timelines and budget
• Direct regional clinical operations team and oversee external partners at regional level
• Ensure regional deliverables align with global study goals and provide regular updates to leadership
• Lead external vendors in regional study delivery and coordinate with CST and stakeholders
• Plan and manage studies from feasibility to closeout for the region, including start-up, recruitment timelines,



and country allocation
• Facilitate site selection, country-level regulatory submissions, and TMF creation/quality control
• Collaborate with CRAs to ensure site monitoring and issue resolution; review monitoring reports
• Oversee data collection, query resolution, and regional data integrity
• Support Clinical Study Report planning and execution with Global Clinical Study Manager and Medical Writing
• Maintain compliance with ICH/GCP and regulatory requirements; prepare for audits and inspections
• Manage regional budget and vendor selections; track resource utilization and contingency planning
• Coordinate local regulatory approvals and reimbursement considerations for comparator drugs

Responsabilidades
• 4 or more years of progressive clinical research experience in biotech, pharma, or CRO
• Proven experience leading clinical functions or teams; CRA experience preferred
• Strong collaboration and stakeholder management skills
• Travel may be required
• Experience with regulatory submissions and study start-up activities

Requisitos principales
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📌 Regional Clinical Study Manager (España)
🏢 Beigene
📍 España