Clinical Study Manager
hace 6 días
Job Title: Clinical Study Manager
Overview:
Mabxience seeks a Clinical Study Manager to oversee the execution of clinical trials, ensuring compliance with established timelines and quality standards. As a key member of our team, you will be responsible for managing the clinical trial plan, communicating any timeline deviations to the Medical Director, and participating in creating contingency plans and corrective measures.
Responsibilities:
• Manage clinical trial plans and timelines
• Communicate with the Medical Director regarding any deviations
• Participate in creating contingency plans and corrective measures
• Select and oversee CROs and external vendors
• Collaborate with study partners and the Medical Director to identify centers and researchers
• Review necessary documentation to obtain approvals from CEICs and Health Authorities
• Create and update the monitoring plan for the study
• Review and approve all trial materials and guidelines
• Supervise IMP control, including distribution, handling, stock management, and destruction
• Oversee blood sample control for pharmacokinetic/pharmacodynamic studies
• Inform and update researchers on all relevant aspects of the clinical trials
• Ensure the quality of participating centers in the monitored studies
• Participate in forming and coordinating Independent Committees (IDMC, IRC, etc.)
• Prepare materials for initial visits to supervised centers
• Draft and coordinate protocol amendments
• Review trial documentation to ensure alignment with plans
• Maintain communication with potential partners
• Create and maintain files for CROs and mAbxience centers
• Conduct co-selection, monitoring, and closing visits as required
• Organize and participate in researcher meetings for the clinical trial
• Create and maintain a tracking system for CRO activities, country-specific activities, recruitment, and vendor management
• Participate in audits
• Ensure compliance with company procedures, Good Clinical Practices, and applicable legislation for all clinical trials under your responsibility
Qualifications:
• Education: Degree in Health Sciences; a Master's degree is a plus
• Languages: Fluent in Spanish and English; additional languages are an asset
• Experience: Over 4 years in a similar role, managing international clinical trials
• Specific Knowledge: Must have knowledge of applicable laws in international clinical trials
• Travel: Willingness to travel
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