Principal CRA – Lead Monitor (m/w/d)
Core
Lead and coordinate clinical monitoring and site management for complex, high-risk clinical trials across diverse therapeutic areas, ensuring compliance with ICH-GCP and EU regulations.
Role type
Principal Clinical Research Associate (Lead Monitor)
Builds
Clinical trial data integrity and regulatory compliance for life sciences therapies
Domain
Life Sciences / Clinical Research
Required skills
Risk-based monitoring (RBM), ICH-GCP compliance, root cause analysis, therapeutic area knowledge, German language fluency (C1), English language fluency (C1), driver's license
Preferred skills
Experience with FSO/FSP monitoring models, mentorship of junior CRAs, process optimization
Technologies
CTMS, Microsoft Office
Responsibilities
Lead on-site and remote monitoring visits; oversee source data verification (SDV) and case report form (CRF) review; manage site initiation, maintenance, and close-out; drive corrective and preventive actions (CAPAs); mentor junior and senior CRAs; serve as key escalation point for site issues.
Seniority
Principal, hands-on IC with leadership responsibilities
