Principal CRA – Lead Monitor (m/w/d)
Core
Lead clinical monitoring and site management for complex, high-risk global clinical trials, ensuring compliance with ICH-GCP and EU regulations while mentoring junior staff.
Role type
Principal Clinical Research Associate (Lead Monitor)
Builds
Clinical trial data integrity and regulatory compliance for life sciences therapies
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring (RBM), ICH-GCP compliance, root cause analysis, site initiation/maintenance/close-out, investigational product accountability, CAPA management, therapeutic area knowledge, medical terminology, Microsoft Office proficiency
Preferred skills
Experience with FSO/FSP monitoring models, audit/inspection leadership, process optimization, cross-functional stakeholder collaboration
Technologies
CTMS, clinical trial systems
Responsibilities
Lead monitoring activities for complex trials using risk-based approaches; Conduct on-site and remote monitoring visits; Perform SDR, SDV, and CRF review; Evaluate investigational product accountability; Lead site initiation, maintenance, and close-out activities; Mentor and coach junior and senior CRAs; Drive corrective and preventive actions (CAPAs) to resolution
Seniority
Principal, hands-on IC with mentorship responsibilities
