5 дней назад
Associate Centralized Monitor (German Speaker)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Centralized Monitor (German Speaker) (Clinical Research): Supporting clinical study teams and monitoring assigned sites to ensure data quality, protocol compliance, and timely issue resolution with an accent on centralized monitoring, subject-level data review, and clinical trial analytics. Focus on identifying site-level risks, trending study metrics, reviewing clinical alerts, and coordinating corrective actions with sites and clinical research associates.
Location: Sofia, Bulgaria
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Provide administrative and operational support to clinical study management teams in line with SOPs, good clinical practice, regulations, timelines, and quality metrics.
- Perform centralized monitoring of assigned sites, reviewing data quality, integrity, protocol compliance, clinical alerts, and study-specific analytics.
- Review subject-level data and follow up with sites and CRAs on missing data, pending queries, SDV backlogs, protocol deviations, visit schedules, and safety information.
- Track site and study performance, identify emerging risks, recommend corrective actions, and review the effectiveness of those actions.
- Maintain clinical systems, databases, trackers, project plans, access requests, reports, and monitoring documentation.
- Support technical solution specialists with Excel formulations, macros, and front-end and back-end tool design; act as a backup for Centralized Monitors and Senior Centralized Monitors.
Requirements
- Graduate or postgraduate degree in Life Sciences or a related field.
- 2–5 years of work experience, including at least 1 year of relevant experience, or an equivalent combination of education, training, and experience.
- Knowledge of clinical research regulations, ICH Good Clinical Practice, and applicable local laws and guidelines.
- Experience with clinical systems such as EDC, IXRS, CTMS, or equivalent platforms, as well as global phase trials or clinical trial data review.
- Good command of German is required. Strong written and verbal English communication skills are also required.
- Strong Microsoft Office, data entry, communication, planning, prioritization, problem-solving, and attention-to-detail skills.
Culture & Benefits
- Full-time position supporting global clinical research programs.
- Work is performed according to defined SOPs, customer requirements, study plans, and regulatory standards.
- Collaboration with clinical study teams, sites, CRAs, managers, clients, vendors, and technical specialists.
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