Regional Clinical Study Manager – Senior Manager

• Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget
• Lead the regional clinical operations team and oversee external regional partners
• Act as point of escalation for regional study issues
• Ensure regional deliverables align with overall study goals
• Lead planning and management of assigned clinical studies from feasibility through regional closeout
• Manage study startup and recruitment timelines and track progress
• Drive trial feasibility, country allocation, and site selection for the assigned region
• Provide regional input on global study plans
• Ensure local adaptations of global study documents and timely regulatory and ethics submissions
• Ensure regional and country information in study systems remains current
• Collaborate with CRAs to ensure proper site execution and review and sign off monitoring reports
• Ensure country and site-level Trial Master Files are created, maintained, and quality controlled
• Provide input on regional drug inventories, local drug labels, regulatory approvals, and comparator reimbursement status
• Manage regional trial data collection, data entry, and query resolution
• Support Clinical Study Report planning and execution
• Monitor compliance with protocols, SOPs, ICH/GCP, and applicable regulations
• Ensure inspection readiness and prepare sites for audits and inspections
• Address escalated site issues and implement solutions
• Lead sharing of site learnings and best practices
• Contribute to work instruction and SOP development and optimization
• Manage regional study vendors and budgets
• Coordinate investigator fees, site payments, and patient travel reimbursement activities
• Identify regional resource needs and monitor resource utilization
• Provide performance feedback and mentor junior team members

• Bachelor’s Degree in a scientific or healthcare discipline required
• Higher Degree preferred
• MS Office proficiency
• Project Planning Applications proficiency
• 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 preferred

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant!)
• In-house and external learning and development opportunities
• Fantastic benefits program
• Dynamic, collaborative, supportive, inclusive, and fun team environment