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Local Clinical Trial Manager
В офисеПолная занятостьУправление проектамиPharmaceuticalsBiotechnology Research
Manage clinical operations and quality for low- to moderate-complexity clinical studies in Israel, ensuring compliant delivery within agreed timelines, quality standards, and budgets.
Обязанности
- Manage clinical operational and quality activities for assigned studies in compliance with ICH GCP
- Develop monitoring plans, monitoring guidelines, data quality plans, and other clinical study tools
- Coordinate Trial Master File setup, document quality, and timely archiving
- Lead clinical teams, meetings, training, and implementation of standardized monitoring processes
- Monitor clinical timelines, metrics, deliverables, budgets, and recovery actions
- Review monitoring visit reports and manage case report form collection and query resolution
- Monitor or co-monitor clinical trials and conduct accompanied field visits when required
- Communicate with study sites regarding protocols, patient participation, case report forms, and study issues
- Coordinate study start-up activities and ethics committee and regulatory submissions
- Manage clinical resources, delegation, assignments, and additional resource requirements
- Support client meetings, bid defenses, project handoffs, forecasts, and financial planning
Требования
- Bachelor’s degree or equivalent formal academic or vocational qualification
- At least 5 years of relevant experience, or an equivalent combination of education, training, and directly related experience
- Knowledge of clinical monitoring practices and requirements
- Understanding of ICH/GCP and relevant regulatory guidelines, including FDA guidelines
- English proficiency
- Experience with budgeting, forecasting, fiscal management, and resource planning
- Strong planning, leadership, communication, judgment, and problem-solving skills
Условия и преимущества
- Collaborative global working environment
- Professional development opportunities
- Work that contributes to scientific and healthcare innovation