Monitoring of clinical trials across various oncology therapeutic areas
Ensuring accurate, complete and timely submission of study data and documents
Preparation of high-quality reports and follow-up letters for monitoring visits
Use of relevant study systems
Participation in international study team meetings and investigator meetings
Support in site selection and assessment of recruitment potential
Initiation of study sites, training, support and guidance of site staff
Monitoring recruitment performance and escalating deficiencies to study management
Proactive communication with the study site and the local study team

University degree in a scientific or medical discipline or equivalent
At least two years of relevant experience as a monitor in the conduct of clinical trials
Enthusiasm for innovative monitoring approaches such as risk-based quality management and remote monitoring
Solid knowledge of ICH-GCP and confident handling of legal and regulatory requirements (e.g., AMG [German Medicines Act] and related regulations)
Strong understanding of medical/clinical issues
Experience with electronic Case Report Forms (Web-Based Data Capture) and preparing monitoring reports
Independent, effective and structured way of working
Analytical and solution-oriented thinking
Team player, flexible and with strong communication skills
Very good command of English

An attractive pipeline and innovative products
Individual development opportunities and a focus on lifelong learning
A high level of trust, appreciation and room to contribute in a focused, passionate team
Office space in the heart of Hamburg enabling collaborative, flexible and agile working
A diverse, inclusive and bias-free work environment
A sustainable company aiming to be CO2-negative across the entire value chain by 2030

Clinical Research Associate – Oncology

Key skills