Clinical Operations Lead

The Clinical Operations Lead (COL) manages clinical project operations, overseeing CRAs and investigator sites to ensure compliance with GCP, ICH, and local regulations. They act as a liaison between the clinical team and CRAs, providing training, support, and performance oversight.

Location: Remote

Salary: €58,000 – €96,500

Responsibilities

• Provide oversight of regional CRAs and investigator sites to ensure compliance with study protocol, GCP, ICH, and local regulations.
• Conduct support visits to aid site/CRA performance.
• Support study team with study deliverables across departments.
• Oversee startup and feasibility activities.
• Assist in vendor management.
• Review visit reports for quality and compliance.
• Manage site and country performance metrics.
• Contribute to financial management processes.
• Manage investigator sites and CRA responsibilities as needed.

Requirements

• College diploma/degree with 7-9 years of related experience or undergraduate degree with 4-6 years of experience.
• Health Sciences, Life Sciences, Nursing background or certifications like SoCRA/ACRP preferred.
• Minimum 3 years CRA experience, proficient with EDC systems and MS Office.
• Strong communication, organizational, and interpersonal skills.
• Knowledge of GCP, local regulations, IRB/EC, and clinical monitoring.