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 communication, drive fit for purpose processes and work towards enhancing overall site satisfaction and engagement.
Establish and develop strong professional relationships with clinical investigators to expand/ maintain clinical research partnership opportunities.
Influence and challenge internal and external factors to improve clinical research delivery.
STUDY START-UP Lead study start-up activities in collaboration with local team.
Collect and perform quality review of essential documents on country level such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc.
Ensure awareness of related local regulations and support maintenance of country intelligence.
Provide study status monitoring and systems support (e.g. Ensure timely and comprehensive resolution of issues that may affectcompliance or the quality of study related activities or data.
Oversee completeness of country/site level eTMF and conduct QC for accuracy, completeness, and adherence to ICH/GCP and Bayer QSDs.
SKILLS &

QUALIFICATIONS:
Healthcare related Bachelor’s Degree or equivalent with minimum 4 years of monitoring and site management experience. Or have a combination of education and minimum 8 years of monitoring and site management experience. Effective written and verbal English and Spanish communication skills. Fundamental project management skills, Decision making, Issue resolutionHome based in SpainLocation:

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