Senior Clinical Research Associate: Global Trials Leader

Alira Health; Netherlands; Remote; EUR 65,000 - 90,000; Full time

Job summary

Alira Health is seeking a permanent Senior CRA in The Netherlands or Belgium to lead clinical monitoring efforts across studies. The role focuses on guiding CRA teams, ensuring adherence to SOPs, timelines, and budgets, and coordinating cross-functional activity with sites and sponsor teams.

The candidate will review visit reports, conduct co-monitoring, manage monitoring plans, and ensure data integrity through source document verification in line with ICH-GCP and regulatory standards.

Qualifications

• BS/BA in life sciences or related field required.
• Minimum 2 years clinical monitoring experience in EU; capable of autonomous monitoring.
• Strong knowledge of ICH-GCP and regulatory requirements.

Responsibilities

• Provide guidance and oversight to CRA team to ensure SOP, scope, timelines and budget adherence.
• Review monitoring visit reports and conduct co-monitoring and evaluations as needed.
• Coordinate site visits and ensure timely investigator site engagement and documentation.
• Manage monitoring plans, site ethics documents, and site contract negotiations as required.
• Prepare and review monitoring visit reports with accurate site issue documentation and action plans.

Skills

Clinical Monitoring

GCP Knowledge

Team Leadership

Cross-functional

Regulatory Knowledge

Education

BS Life Sciences

Tools

CTMS

eTMF

Job description

Alira Health is seeking a permanent Senior CRA in The Netherlands or Belgium to lead clinical monitoring efforts across studies. The role focuses on guiding CRA teams, ensuring adherence to SOPs, timelines, and budgets, and coordinating cross-functional activity with sites and sponsor teams.

The candidate will review visit reports, conduct co-monitoring, manage monitoring plans, and ensure data integrity through source document verification in line with ICH-GCP and regulatory standards.