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

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