Senior Clinical Research Associate I/II | Senior CRA I/II - Senior Klinischer Monitor (m/w/d)
Microgenics B.V. & Co. KG
Job Summary
As a Senior Clinical Research Associate at Thermo Fisher Scientific (PPD), you will play a vital role in managing clinical trial sites across Germany. Your daily activities will involve both on-site and remote monitoring using risk-based monitoring (RBM) approaches to ensure compliance with ICH-GCP, protocols, and regulatory requirements. You will be responsible for source data verification (SDV), investigational product accountability, and maintaining inspection readiness while building strong relationships with investigators. This role is highly autonomous, requiring you to identify and resolve issues through root cause analysis and CAPA principles. The position is particularly attractive due to its flexibility, offering permanent employment with full-time or part-time options, and the ability to work either home-based or in a hybrid model from various German cities. You will be part of a global leader in clinical research with clear career progression pathways into leadership roles like Lead CRA or Clinical Team Manager.
Required Skills
Education
Bachelor’s degree in a life sciences related field or equivalent qualification
Experience
- Minimum 2+ years of experience as a Clinical Research Associate / Monitor
- Professional experience in independent site monitoring and management
- Proven experience in risk-based monitoring (RBM) approaches
- Experience in documenting monitoring activities and writing high-quality reports
- Experience in study start-up, site initiation, and study close-out activities
Languages
Additional
- Valid driver’s license; Full right to work in Germany; Travel requirement approximately 50–75% (study-dependent); Available for full-time (40h) or part-time (32h) work.
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