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Ergomed
Ergomed
4 open remote positions
Ergomed is a specialist clinical research organization focused on rare disease and oncology clinical trials. They have built a collaborative, international team across multiple continents, valuing teamwork, flexibility, and work-life balance.
Benefits Overview
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Open Positions
Leads a global team of Statistical Programmers, overseeing SDTM, ADaM, and TLF deliverables. Ensures quality, budget, and timeline adherence while mentoring team members. Contributes to process improvements and strategic initiatives to enhance operational efficiency.
SAS
R
Perform on-site or remote monitoring visits to ensure site adequacy for clinical studies. Verify investigator qualifications and support regulatory submissions. Train site staff and ensure compliance throughout the study period.
Clinical Research
Site Management
French
Regulatory Affairs
Communication
Lead the study start-up process, developing strategy and coordinating regulatory deliverables to meet targets. Serve as primary contact for start-up activities, prepare and review regulatory documents, and ensure compliance with ICH-GCP and regulations. Manage essential document collection, site correspondence, contract negotiations, and support team training and budget monitoring.
Project Management
Regulatory Compliance
ICH-GCP
Clinical Research
Communication
Lead the design, analysis, and interpretation of clinical studies for rare disease and oncology trials. Oversee all contracted statistical activities, including protocol development, statistical analysis plans, and data review. Provide mentorship to junior statisticians and represent the biostatistics function in cross-functional meetings and audits.
Biostatistics
SAS
Statistical Programming
Communication