Senior CRA I/II - Senior Klinischer Monitor (m/w/d)
Core
Managing clinical trial sites across Germany to ensure compliance with protocols, ICH-GCP, and regulations through risk-based monitoring.
Role type
Senior Clinical Research Associate (CRA)
Builds
Global clinical trials for life-changing therapies
Domain
Clinical research / Healthcare
Deliverable
client delivery
Required skills
Risk-based monitoring, Protocol compliance, ICH-GCP knowledge, Investigational product accountability, Root cause analysis, CAPA principles, Audit readiness, Data quality management, Site initiation support, Study close-out support
Preferred skills
Process improvement, Mentoring
Technologies
CTMS
Responsibilities
Perform on-site and remote monitoring visits, Conduct source data verification (SDV) and case report form (CRF) review, Identify and resolve issues using root cause analysis, Maintain audit and inspection readiness, Provide trial status updates and metrics to the Clinical Team Manager, Support study start-up and close-out activities
Seniority
Senior, hands-on IC