Description

In this role, you will support the clinical team by managing essential documentation and data for clinical trials. Your day-to-day responsibilities will involve collaborating with various departments, ensuring compliance, and assisting with site visits to enhance trial efficiency.

Requirements

• •Bachelor’s or higher-level degree in life science or High School Diploma and apprenticeship in life science, medical or pharmaceutical field, or office management
• •2 years or more of experience as Clinical Trials Assistant or in another administrative role in clinical research, or at least 3 years experience as working student in clinical research
• •Excellent knowledge of clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• •Fluent language skills in German on at least C1 level and good command of English
• •Computer skills including working knowledge of Microsoft Word, Excel, and PowerPoint
• •Effective communication, organizational, and planning skills
• •Ability to work independently and effectively prioritize tasks
• •Flexibility to visit client's office for meetings in Hamburg area 2-3 days/week or according to an agreed schedule

Tasks

• •Assist Clinical Research Associates with updating and maintaining clinical documents
• •Support the clinical team in preparing, handling, and archiving clinical documentation
• •Conduct periodic reviews of study files for completeness
• •Help with the distribution and tracking of Clinical Trial Supplies
• •Manage Case Report Forms, queries, and clinical data flow
• •Serve as a central contact for project communications and documentation
• •Accompany CRAs on site visits to assist with clinical monitoring duties

Tools & Technologies