Beschreibung

As a Global Clinical Trial Coordinator, you will play a vital role in managing early clinical trials, supporting various stakeholders, and ensuring compliance with regulatory standards. Your day-to-day responsibilities will involve coordinating documentation, maintaining timelines, and facilitating effective communication across teams.

Anforderungen

• •Bachelor’s or higher-level degree in Business Administration, Life Science or equivalent
• •Vocational training with extensive experience in clinical and regulatory environments
• •At least 5 years’ experience as Clinical Trial Coordinator or similar role in clinical research
• •Strong knowledge of clinical research regulatory requirements, i.e., GCP and ICH guidelines
• •Excellent administrative and organizational skills
• •Strong communication and interpersonal skills
• •Proficiency in MS Office and eTMF systems (e.g., Veeva, BIRDS)
• •Fluent language skills in German on at least C1 level
• •Good command of English
• •Ability to work independently, prioritize tasks, and manage multiple projects

Aufgaben

• •Coordinate early clinical trials for sponsors and study sites
• •Support Clinical Trial Leaders and Managers in study activities
• •Prepare and manage clinical trial documentation
• •Compile and collect submission documents
• •Maintain trial-specific data and timelines in electronic systems
• •Communicate with internal and external partners
• •Organize and monitor study-related activities and meetings
• •Ensure timely preparation of submission documents for authorities
• •Manage essential documents for Investigator Site File
• •Ensure Trial Master File completeness and compliance
• •Oversee TMF strategy and perform quality checks
• •Maintain List of Expected Records for TMF
• •Ensure audit and inspection readiness
• •Participate in process harmonization initiatives
• •Support implementation of new systems
• •Assist in finalizing Clinical Trial Reports and appendices

Tools & Technologien

Benefits