Clinical Operations Lead

About the Role

Join our global team as Clinical Operations Lead.

The Clinical Operations Lead is responsible for the clinical operations of a project at a defined regional/global level. You will provide oversight of project deliverables, assigned Clinical Research Associates (CRAs), and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines, and local regulations.

Position is open in any EU country. All CVs must be submitted in English.

Responsibilities

• Oversee a group of study CRAs to ensure site compliance with study protocol, study plans, ICH-GCP, local regulations, and study timelines.
• Conduct monitoring support visits (accompanied site visits) per project requirements to assist sites/CRAs in satisfactory performance and compliance.
• Develop training materials and study tools for sites and CRAs, including monitoring plans.
• Develop and implement enrollment and recruitment strategies in conjunction with the clinical project team.
• Support the clinical project team by overseeing study deliverables related to other functions (e.g., Data Management, TMF Operations, etc.).
• Proactively manage site and country performance (recruitment, data collection, document collection, TMF review, timely update of Biomapas/sponsor CTMS by CRAs) and inform the clinical project team of progress.
• Oversee regional startup and feasibility activities.
• Provide project training and mentoring to regional CRAs on study procedures, clinical plans, guidelines, and timelines.
• Assist in vendor management activities as required per project.
• Review visit reports for quality, compliance, and appropriate site management.
• Assure compliance with high-quality and timely project deliverables according to project requirements and the monitoring plan.

Requirements

• Bachelor’s or Master’s Degree in Medicine, Pharmacy, or Life Sciences.
• 3 years of experience in a Clinical Lead role.
• Fluent written and spoken English language skills.
• Good coordination skills.
• Attention to detail, time-management, and problem-solving skills.
• Strong organization and analytical skills.

Benefits

• Professional growth and career opportunities.
• International team and environment.
• Bonus based on annual performance.
• Personal accident and business trip insurance.
• Additional health insurance.
• Remote/home-based work.
• Complimentary health and wellness benefits, such as influenza vaccines.
• Rewarding referral policy.
• Workplace establishment allowance (fully remote).
• Team building, global meetings, and B active events.