Clinical Trial Associate fluent German
- 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 German 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