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Site Manager

Sobre el puesto

• Facilitate the conduct of clinical studies
• Provide patient-related site support according to study-specific site management plans
• Maximize utilization of site staff through training and oversight for logistically or technically demanding study procedures
• Ensure clinical studies progress and comply with protocols, Ergomed SOPs, ICH GCP, and applicable regulatory requirements
• Act as the primary contact for Study Site Coordinators and Research Nurses
• Participate in Site Manager training
• Provide continuous training, consultation, support, and supervision of Study Site Coordinators
• Assist with patient recruitment and retention strategies and track recruitment activities
• Oversee investigational medicinal product and clinical trial supplies inventory
• Facilitate logistics for shipment of samples
• Notify LSM, CRA, CTM, or PM of detected site issues
• Maintain relationships with site coordinators, research nurses, investigators, and sub-investigators
• Participate in internal team teleconferences and site management meetings
• Prepare Site Management Visit reports after on-site or remote visits
• Ensure visit reports, phone contact reports, and relevant correspondence are filed in the eTMF
• Support management of patient travel and other expenses, calculation sheets, and site invoicing

• Educated to degree standard, preferably in medical/public health, or appropriate equivalent work experience
• Previous experience conducting site management/site support activities
• Knowledge of clinical trial protocols and site management processes
• Knowledge of Ergomed standard operating procedures (SOPs)
• Knowledge of ICH GCP and applicable regulatory requirements
• Ability to support patient recruitment and retention strategies
• Ability to oversee investigational medicinal product (IMP) and clinical trial supplies inventory
• Ability to prepare site management visit reports, phone contact reports, and filing correspondence in the eTMF
• Ability to support patient travel expenses, calculation sheets, and site invoicing
• Ability to work with Study Site Coordinators, Research Nurses, Investigators, and Sub-Investigators

• Remote work availability
• Work-life balance
• Career growth opportunities
• Collaborative, international team environment
• Meaningful work supporting patients
• Passionate and collaborative team of experts
• Inclusive workplace where every voice counts