12 часов 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; fully remote with country-wide monitoring and an average of 6 onsite days per month
Company
supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics.
What you will do
- Deliver timely, high-quality monitoring reports for sponsor approval in line with clinical monitoring plan timelines.
- Conduct remote and onsite monitoring visits with a focus on data integrity, patient safety, and country-specific regulations.
- Plan daily monitoring activities and set priorities for investigator sites.
- Prepare and conduct site qualification, study initiation, interim monitoring, and close-out visits.
- Maintain TMF/eTMF documentation according to filing guidelines and ICH/GCP Section 8 requirements.
- Review site documents for accuracy, completeness, currency, and required updates.
Requirements
- Undergraduate degree or international equivalent in a clinical, science, or health-related field, a registered nursing license, or equivalent work experience.
- Previous clinical research experience.
- At least 4 years of experience in clinical trials and independent monitoring.
- Experience in Neurology, Oncology, Rare Disease, and/or Pediatrics.
- Preference for experience across Phase I–IV clinical trials; candidates with Phase II and III experience will also be considered.
- Ability to conduct country-wide monitoring in Germany, including an average of 6 onsite days per month.
Culture & Benefits
- Fully remote work arrangement with required site monitoring travel within Germany.
- Flexibility and work-life balance support.
- Opportunities for professional growth, skills development, and career progression.
- Input into working practices and the opportunity to contribute to medical innovation.
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