Global Clinical Operations Lead: CRA Oversight & Strategy

Alimentiv; USA; Remote; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Alimentiv is seeking a Clinical Operations Lead to oversee regional/global CRA activities and site performance within the monitoring plan and GCP framework. You will train CRAs, coordinate visits, and drive enrollment strategies while maintaining compliance with protocols and regulatory requirements.

The role involves developing tools for site and CRA use, reviewing visit reports, and supporting the clinical project team with performance metrics, issue escalation, and timely deliverables.

Qualifikationen

• Experience leading clinical operations or monitoring teams.
• Knowledge of GCP/ICH guidelines and local regulations.
• Ability to train and mentor CRAs and coordinate with project teams.

Aufgaben

• Provide overall oversight of regional CRAs and ensure site compliance with study protocol, plans, ICH-GCP, and regulations.
• Coordinate monitoring support visits and ensure quality and timely deliverables per plan.
• Oversee startup and feasibility activities and assist in vendor management.
• Review visit reports, protocol deviations, and TMF to ensure data integrity.
• Escalate issues and implement corrective actions; monitor recruitment and data collection.
• Develop study tools and provide guidance to CRAs and the clinical project team.
• Act as primary liaison between CRAs and the clinical project team to ensure alignment.

Kenntnisse

Leadership

Global oversight

CRA training

Regulatory knowledge

Communication

Jobbeschreibung

Alimentiv is seeking a Clinical Operations Lead to oversee regional/global CRA activities and site performance within the monitoring plan and GCP framework. You will train CRAs, coordinate visits, and drive enrollment strategies while maintaining compliance with protocols and regulatory requirements.

The role involves developing tools for site and CRA use, reviewing visit reports, and supporting the clinical project team with performance metrics, issue escalation, and timely deliverables.