GET TO KNOW OUR AREA:

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.

YOUR MISSION WILL BE TO:

• 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 t...