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.

Responsabilidades

- 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

Requisitos principales

- 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

- Cross-functional collaboration
- Stakeholder management
- Problem solving
- Knowledge of ICH-GCP and regulatory requirements
- Experience with monitoring plans and start-up documentation
- Site qualification and Investigator Site File management

📌 Clinical Operations Manager 2 (Barcelona)
🏢 Bayer
📍 Barcelona