22 oct
|
Bayer
|
Barcelona
Experteer Overview
In this role you lead regional site and study management activities for Phase I–IV trials, ensuring compliance with ICH-GCP and Bayer SOPs. You act as the study management and site management representative on core teams and shape monitoring strategies, start-up approaches, and quality plans.You will collaborate with cross-functional teams to align timing, budget, and data integrity, while driving recruitment, training, and country-specific execution. This role gives you impact by improving trial delivery and stakeholder partnerships in a general setting.
Compensaciones / Beneficios
• Lead operational site management from feasibility to study close-out at regional or study level
• Represent site management on the core study team and influence protocol, monitoring strategy, and risk-based quality management
• Develop monitoring and study-specific training plans; contribute to recruitment and retention strategies
• Serve as country study contact and manage timelines, budget, and quality across assigned countries
• Ensure data accuracy in IT systems and oversee monitoring activities and sponsor oversight via reports and co-monitoring visits
• Act as primary site contact, qualify sites, train staff on protocol and systems, and ensure ICH-GCP and regulatory compliance
• Manage site qualification, Investigator Site File completeness, and onsite/remote monitoring per plan
• Cultivate client relationships, drive cross-functional collaboration, and improve site satisfaction and engagement
• Lead study start-up activities, review essential documents, prepare submission dossiers, and ensure timely TMF filing
• Support quality assurance activities including CAPA, site audits, regulatory inspections, and eTMF QC
Responsabilidades
• Healthcare related Bachelor’s Degree or equivalent with minimum 4 years of monitoring and site management experience
• Or a combination of education and minimum 8 years of monitoring and site management experience
• Experience in Spain
• Effective written and verbal English and Spanish communication
• Fundamental project management, decision making, and issue resolution skills
• Home-based in Spain
Requisitos principales
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📌 Clinical Operations Manager 2 (Barcelona)
🏢 Bayer
📍 Barcelona