
1001 - 5000 employés
Fondée en 1997
💼 Conseil
🏥 Santé
📦 Logistique
Consulting • Healthcare • Logistics
ERGOMED est un groupe international qui fournit des services spécialisés aux industries biotechnologique et pharmaceutique. Il opère à travers plusieurs lignes de services, notamment Ergomed Clinical Research, PrimeVigilance et ADAMAS Consulting, et se consacre à offrir des capacités complètes de CRO (Contract Research Organization). Axé sur l’oncologie, les maladies rares et les essais complexes, il propose également des services de pharmacovigilance et d’information médicale de bout en bout, ainsi que des audits GxP complets. Ergomed s’engage à accompagner le développement de médicaments, avec une présence mondiale dans une centaine de pays environ.
🕒 il y a 11 jours
🗣️🇺🇸🇬🇧 Anglais requis
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1001 - 5000 employés
Fondée en 1997
💼 Conseil
🏥 Santé
📦 Logistique
Consulting • Healthcare • Logistics
ERGOMED est un groupe international qui fournit des services spécialisés aux industries biotechnologique et pharmaceutique. Il opère à travers plusieurs lignes de services, notamment Ergomed Clinical Research, PrimeVigilance et ADAMAS Consulting, et se consacre à offrir des capacités complètes de CRO (Contract Research Organization). Axé sur l’oncologie, les maladies rares et les essais complexes, il propose également des services de pharmacovigilance et d’information médicale de bout en bout, ainsi que des audits GxP complets. Ergomed s’engage à accompagner le développement de médicaments, avec une présence mondiale dans une centaine de pays environ.
• 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
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