Clinical Trial Associate fluent GERMAN

Clinical Trial Associate fluent German
CTA role provides technical support to the clinical trial capabilities team in support of clinical development. The assistant is responsible for activities related to investigator sites readiness, maintenance and close out. The assistant will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional country specific responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences. 
Job Description
Initiate investigator site activities, including collection and submission of 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 sites during maintenance and close-out
Support TPO and investigator payments as appropriate
Manage site account requests
Invoice query resolutions
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 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 trial prioritization
Anticipate and monitor dynamically changing priorities

Minimum Qualification 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
 


Required language: German