• Initiate investigator site activities, including collection and submission of clinical regulatory documents.
• Track and ensure site compliance to effectively drive timelines aligned with company priorities
• Communicate directly with sites to enable start-up and maintain an active collaboration with clinical sites during maintenance and close-out
• Support TPO and investigator payments as appropriate
• Identify, communicate, and resolve issues
• Accountable for accurate and complete data entry of clinical trial information into various clinical trial systems to allow tracking, performance metrics reporting and to meet regulatory compliance requirements.
• Ensure appropriate archiving of documents to meet company record retention policies and regulatory requirements.
• Ensure inspection readiness through a complete, accurate and readily available Trial Master File
• Communicate directly with clinical sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
• Identify, communicate, and resolve issues
• Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
• Leverage previous site / review board engagements to efficiently drive new work
• Populate internal systems to ensure accuracy of trial / site performance
• Understand and comply with procurements, legal and financial requirements and procedures
• Populate Trial Master Files and libraries for future reference
• Provide feedback and shared learning for continuous improvement
• Leverage clinical trial prioritization
• Anticipate and monitor dynamically changing priorities

Requirements:

• A degree or equivalent preferably in a scientific or health related field,
• Two years clinical research experience or relevant experience preferred
• Fluent Polish speaker and fluency in English is essential for this role.
• Applied knowledge of project management processes and skills
• Appreciation of / experience in compliance-driven environment
• Ability to learn and comply with regulatory requirements and internal policies.
• Effective communication, team work and problem solving skills
• Very good attention to details and accuracy
• Self-management and organizational skills
• Excellent computer skills