обновлено 13 дней назад
Clinical Research Associate II
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate II (Clinical Monitoring): Conducting remote and onsite monitoring for clinical studies in Germany with an accent on data integrity, patient safety, and regulatory compliance. Focus on planning site activities, conducting qualification and monitoring visits, maintaining TMF/eTMF documentation, and supporting studies across multiple therapy areas and clinical trial phases.
Location: Germany; must be located in Germany. Country-wide monitoring is required, with an average of 6 days per month onsite at investigator sites. Monitoring may be remote, onsite, or another approved mode.
Company
supports biotech, medtech, and specialty pharma organizations in developing medicines, medical devices, and diagnostics.
What you will do
- Deliver timely, high-quality monitoring reports for sponsor approval according to Clinical Monitoring Plan timelines.
- Plan daily monitoring activities and set priorities for each investigator site.
- Prepare for and conduct site qualification, study initiation, interim monitoring, and close-out visits.
- Monitor clinical studies with a focus on data integrity, patient safety, and applicable country regulations.
- Maintain the Trial Master File and electronic Trial Master File according to filing guidelines and organizational processes.
- Review site documents for accuracy, completeness, currency, and required updates, while managing monitoring-related expenses.
Requirements
- Undergraduate degree or international equivalent in a clinical, science, or health-related field, a licensed healthcare qualification such as registered nursing, or equivalent work experience.
- Previous clinical research experience.
- At least 4 years of experience in clinical trials and independent monitoring.
- Experience across some or all of the following therapy areas: neurology, oncology, rare disease, and pediatrics.
- Experience across phases I–IV is preferred; candidates with phase II and III experience will also be considered.
- Must be located in Germany and available for country-wide monitoring with approximately 6 onsite days per month.
Culture & Benefits
- Flexible working arrangements designed to support work-life balance.
- Opportunities to develop skills and advance professionally.
- Employee input is encouraged in shaping how work is performed.
- Work contributes to the development of medicines, devices, and diagnostics intended to improve patient lives.
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