
1001 - 5000 employees
Founded 1997
đź Consulting
đĽ Healthcare
đŚ Logistics
Consulting ⢠Healthcare ⢠Logistics
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
đĽ 12 minutes ago
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1001 - 5000 employees
Founded 1997
đź Consulting
đĽ Healthcare
đŚ Logistics
Consulting ⢠Healthcare ⢠Logistics
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
⢠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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