Experteer Overview
In this role, you lead the Clinical Site Management (CSM) strategy for assigned studies, ensuring timely, compliant site activities from planning through close-out. You align with Clinical Development Operations and key stakeholders to secure study-level CSM deliverables within resources and timelines. You drive site selection, activation, engagement, and monitoring quality while proactively managing risks and facilitating inspection readiness. This position offers impact through shaping study execution and ensuring data integrity in a fast-paced, cross-functional environment.
Compensaciones / Beneficios
• Plan and validate CSM deliverables within study timelines and resource constraints
• Lead study-level CSM strategy, Site Monitoring Plan, and Site Engagement Strategy
• Oversee site selection, activation, engagement, protocol adherence, and close-out at the study level
• Coordinate monitoring activities with SMLs, ensuring quality, tracking, and milestone adherence
• Manage data snapshots, database locks, and Site Closure Plan alignment
• Identify, evaluate, and mitigate risks with action plans (RAMP collaboration)
• Ensure site compliance, trend analysis, and continuous improvement
• Contribute to study-level CSM documentation and TMF completeness
• Maintain ongoing CSM inspection readiness throughout the study
Responsabilidades
• Bachelor's Degree or equivalent in a (para)medical or scientific field
• Minimum 7 years of industry clinical research experience including 2 years in monitoring or project management on a general study
• Minimum 1 year global project management experience
• Experience in initiation through completion across multiple study phases (Phase II/III; Phase I in patients) and multiple therapeutic areas
• Strong communication and leadership abilities; ability to influence in a matrix environment
• Proficiency in standard procedures (SOPs, ICH, global regulations, ethics and compliance)
• Excellent written and verbal English; strong planning and organizational skills; team-oriented and autonomous
• Advanced skills in Microsoft Word, PowerPoint, Excel, and OneNote
Requisitos principales
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📌 Senior Site Management Lead (Madrid)
🏢 Abbvie
📍 Madrid