Monitoring of clinical studies in the field of cell therapy (e.g., CAR-T, TCR-T, Treg), including ensuring correct, complete and timely transmission of study data and documents, and active involvement in all study phases (feasibility, set-up, recruitment, maintenance, database lock (DBL), closure)
Timely preparation of high-quality monitoring visit reports and follow-up letters
Confident use of relevant study systems (e.g., WBDC, IVRS) and maintenance of the CTMS
Participation in international study team meetings and investigator meetings
Contribution to site selection and assessment of recruitment potential
Site initiation, training, support and guidance of site personnel
Continuous monitoring of recruitment performance, site performance and quality, and escalation of deficiencies to study management
Proactive communication with the study site and the local study team

Completed degree in a natural science, medicine or equivalent
Demonstrable prior experience as a monitor in clinical studies with cell therapy (e.g., CAR-T, TCR-T, Treg)
Interest in modern monitoring approaches such as Risk-Based Quality Management and Remote Monitoring
Excellent ICH-GCP knowledge for the proper conduct of clinical trials
Knowledge of the relevant laws (AMG) and regulatory requirements (AMG = German Medicinal Products Act)
Good understanding of medical issues
Understanding of different study and process requirements and the ability to set the right priorities accordingly
Experience monitoring electronic Case Report Forms (Web-Based Data Capture) and preparing monitoring reports
Very good German and English language skills
Structured, independent organization as well as analytical and solution-oriented thinking
Strong team spirit and excellent communication skills
Willingness to travel, including overnight stays

Individual development opportunities and a focus on lifelong learning
A high level of trust, appreciation and scope for personal contribution in a focused, passionate team
Office space in the heart of Hamburg that supports collaborative, flexible and agile working
A diverse, inclusive and non-discriminatory working environment committed to the Charta der Vielfalt (Diversity Charter), which not only allows but actively promotes differences and welcomes applications from all qualified candidates regardless of their characteristics
A sustainable company aiming to become CO2-negative across the entire value chain by 2030

Clinical Research Associate – Cell Therapy, Field-based

Key skills