Monitoring of clinical trials in the field of cell therapy (e.g., CAR‑T, TCR‑T, Treg)
Ensuring accurate, complete and timely transmission of study data and documents
Active involvement in all study phases (feasibility, set‑up, recruitment, maintenance, DBL [database lock], closure)
Timely preparation of high‑quality monitoring visit reports and follow‑up letters
Confident use of relevant study systems, e.g., Web‑Based Data Capture (WBDC), IVRS
Maintenance of the CTMS
Participation in international study team meetings and investigator meetings
Support in site selection and assessment of recruitment potential
Site initiation, training, support and guidance of site staff
Continuous monitoring of recruitment performance, site performance and quality
Escalation of deficiencies to study management
Proactive communication with study sites and the local study team

Degree in a natural science or medical field, or equivalent
Proven prior experience as a monitor in clinical trials involving cell therapy (e.g., CAR‑T, TCR‑T, Treg)
Interest in modern monitoring approaches such as risk‑based quality management and remote monitoring
Excellent knowledge of ICH‑GCP for the proper conduct of clinical trials
Knowledge of applicable laws (e.g., AMG) and regulatory requirements
Good understanding of medical issues and clinical questions
Understanding of different study and process requirements and the ability to set appropriate priorities
Experience monitoring electronic Case Report Forms (Web‑Based Data Capture) and in preparing monitoring reports
Very good German and English language skills
Structured, independent organization as well as analytical and solution‑oriented thinking
Strong team skills and excellent interpersonal and communication skills
Willingness to travel, including overnight stays

Individual development opportunities and a focus on lifelong learning
A high level of trust, appreciation and room to contribute in a focused and passionate team
Office space in the heart of Hamburg enabling collaborative, flexible and agile working
A diverse, inclusive and non‑discriminatory work environment committed to the Charta der Vielfalt (Charter of Diversity) that actively promotes differences and welcomes applications from all qualified candidates regardless of their characteristics
A sustainable company aiming to be CO2‑negative across the entire value chain by 2030

Clinical Research Associate, Cell Therapy – Field-Based

Key skills