• Responsibility to deliver key milestones of assigned projects
• Development and maintenance of the overall project plan and includes all activities critical to the project’s success.
• Management of individual activities within the overall project plan, which may include study level activities such as study protocol development, planning for study execution and management of key clinical trial project meetings
• Management of external vendors contracted to execute clinical trial related activities Responsibility to deliver clinical operation activities to the SOPs, local and national guidelines.
• Reporting clinical trial status and issues to the line manager and senior management. Presenting contingency planning and risk mitigation plans to senior management
• Building and maintenance of the project budget
Qualifications and experience:
• Educated to at least degree level with a strong scientific background
• At least 5 years’ experience working on clinical development projects, ideally with both early and late phase clinical development experience, day to day management of clinical trial activities and reporting clinical trial status and issues.
• Experience of working in an outsourced environment, managing multiple vendors
• Previous experience of written and face-to-face interactions with regulatory authorities in EU and USA
• Experience in building and maintaining study and project budgets