Clinical Operations Manager 2 (COM2)
The COM 2 is a regional role that provides expertise across all aspects of clinical site management and/ or study management for assigned Phase I – IV studies. The COM 2 operates in line with Good Clinical Practices (ICH-GCP), applicable regulatory and legal requirements and Bayer’s standard operating procedures.
The COM 2 may be assigned work packages in areas of study start-up, site management and study management on a regional level. Either one or a combination of these work packages may be allocated to the position holder according to expertise, skill set and capacity requirements in a adaptable way. The COM 2 must acquire knowledge and adequate training for work packages assigned and become proficient in independently executing assigned responsibilities.
STUDY MANAGEMENT
Lead and oversee all operational aspects of site management on a regional or study level from protocol feasibility to study archive. Serve as the representative for site management on the core study team. Contribute to the development of the protocol, study overview,



monitoring strategy and Risk Based Quality Management with regards to monitoring and operational aspects. Responsible and accountable for developing the monitoring plan and the study-specific training plan. Key contributor in the development of recruitment and retention strategies and tools. Act as key study contact for assigned countries. Responsible for overall deliverables regarding timelines, budget, and quality in assigned countries. Ensure participating country commitment aligns with study commitments. Provide the information required to effectively monitor and manage study activities, ensuring all relevant IT systems are updated with precise and current data. Oversee monitoring activities and ensure sponsor oversight through monitoring report review and co-monitoring visits. SITE MANAGEMENT
Act as primary contact for investigational sites. Verify site qualification, ensure the Investigator

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