Join our Talent Pool - Clinical Operations Lead (Europe)

We are inviting qualified candidates to join our talent pool for Clinical Operations Lead needs in Europe. The ideal candidate will have experience in clinical operations and will be responsible for overseeing regional CRAs, leading monitoring activities, and serving as a liaison between CRAs, project teams, and sponsors.

Requirements

• Provide overall oversight of regional CRAs to ensure site compliance with study protocols, ICH-GCP, local regulations, and project timelines.
• Lead and support monitoring activities, including co-monitoring visits and quality review of monitoring reports.
• Actively manage site, country, and regional performance (startup, recruitment, data quality, TMF, and timelines), escalating risks and issues as needed.
• Serve as the primary operational liaison between CRAs, project teams, and sponsors, delivering regular status updates and guidance.
• Train, mentor, and support CRAs on study-specific procedures, expectations, and performance standards.
• Oversee study startup, feasibility, and site management activities, including temporary direct site oversight when required.
• Contribute to project planning, financial oversight, and vendor coordination as applicable.
• Develop and deliver key study documents, tools, and presentations for sponsors, investigators, and study teams.
• Provide strategic oversight of Clinical Operations Leads (COLs) and regional CRAs to ensure compliance with study protocols, ICH-GCP, local regulations, and timelines.
• Lead study-level monitoring and site management deliverables, including visit quality, recruitment, essential documents, and adherence to monitoring plans.
• Oversee country and site startup, feasibility, and vendor management activities, contributing to country/site selection strategy.
• Serve as the primary monitoring and site management liaison with sponsors, project teams, and internal stakeholders.
• Provide leadership, training, mentoring, and performance oversight for COLs and CRAs, including CRA assessments.
• Ensure high-quality, timely study execution, including financial oversight related to monitoring budgets, site payments, and pass-through costs.
• Contribute to or lead overall trial management for smaller or limited-scope clinical studies when required.
• Act as a subject matter expert, supporting process improvement initiatives, mentoring COLs, and representing Clinical Operations internally and externally.

Benefits

• Health
• Dental
• Performance-based bonus