05 ago
|
Talent
|
Barcelona
Experteer Overview
In this role you lead global study start-up efforts to activate sites efficiently and align with sponsor goals. You collaborate cross-functionally to shape SSU strategy, manage timelines, and ensure compliant regulatory and contractual pathways. You drive end-to-end activation from site identification to IP release, delivering start-up excellence at scale. This position offers impact across multi-country trials and an opportunity to shape delivery through proactive risk management and continuous improvement.
Compensaciones / Beneficios
• Shape and execute Study Start-Up strategies for global, multi-country studies to meet timelines and sponsor expectations
• Develop and deliver comprehensive Study Start-Up Plans covering regulatory, ethics, and contract execution
• Drive end-to-end start-up activities from site identification to IP release, keeping milestones on track
• Provide strategic input at Bid Defence and Kick-Off meetings to influence study design and start-up feasibility
• Oversee regulatory and ethics submissions ensuring timely, compliant approvals
• Manage site contracts and budgets with legal, finance, and sponsors to enable timely activation
• Identify risks and bottlenecks and implement mitigation and escalation plans
• Collaborate with Project Managers and cross-functional teams to integrate start-up into overall study delivery
• Ensure accuracy and readiness of study documentation,
overseeing CTMS and eTMF activities
• Lead and coordinate the Study Start-Up team, providing direction and oversight
• Promote process consistency and continuous improvement across regions
• Maintain oversight of study metrics, budgets, and scope of work (SOW)
• Provide clear reporting to sponsors and leadership for informed decision-making
• Contribute to a culture of performance, collaboration, and accountability aligned with ICON values
Responsabilidades
• Experience managing Study Start-Up (SSU), feasibility, or site activation in clinical research
• Experience on integral or multi-country clinical studies
• Strong knowledge of regulatory and ethics submission processes
• Experience coordinating site contracts and budgets
• Ability to manage timelines, risks, and competing priorities
• Familiarity with CTMS, eTMF, and clinical trial systems
• Solid understanding of ICH-GCP and regulatory frameworks
• Strong stakeholder management and communication skills
• Ability to collaborate across cross-functional, global teams
• Structured, proactive, and solution-oriented approach
Requisitos principales
• Annual leave entitlements
• Health insurance offerings
• Retirement planning options
• Global Employee Assistance Programme
• Life assurance
• Flexible country-specific benefits
📌 Project Manager, Feasibility Site Activation (Barcelona)
🏢 Talent
📍 Barcelona