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.

Siga leyendo para comprender completamente lo que este trabajo requiere en cuanto a habilidades y experiencia. 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.

The COM 2 must acquire knowledge and adequate training for work packages assigned and become proficient in independently executing assigned responsibilities.STUDY MANAGEMENTLead 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.Responsible for overall deliverables regarding timelines, budget, and quality in assigned countries.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.Monitor trial conduct in compliance with the study protocol, ICH-GCP and applicable regulatory requirements on time and quality.

Prepare and conduct onsite and/or remote monitoring activities according to monitoring plan, including complete reporting and follow up.CLINICAL CUSTOMER ENGAGEMENT Cultivate and sustain customer relations with clinical trial sites, ensure effective communi

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