обновлено 22 часа назад
Senior Clinical Research Associate (Netherlands)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate (Netherlands) (Clinical Monitoring): Conducting on-site and remote monitoring, site management, and study-document oversight for clinical trials with an accent on GCP compliance, data quality, and inspection readiness. Focus on leading feasibility and monitoring visits, resolving deviations and data queries, and coordinating complex studies and CRA activities.
Location: Remote, Netherlands; on-site and remote monitoring required, with travel of up to 80%.
Company
provides clinical trial delivery, home health services, expanded access programs, and market access consultancy for biopharmaceutical sponsors.
What you will do
- Contribute to protocols, CRFs, informed consent forms, study plans, monitoring plans, and other study documents.
- Lead site feasibility activities, including questionnaires, site qualification visits, evaluations, and site selection recommendations.
- Plan and conduct site initiation, routine monitoring, and close-out visits in accordance with protocols, ICH-GCP, and regulatory requirements.
- Verify source data, CRFs, essential documents, investigational product accountability, safety documentation, and protocol deviations.
- Manage data queries, corrective and preventive actions, monitoring deliverables, and study action items.
- For assigned Lead CRA responsibilities, oversee complex studies, finalize visit reports, develop monitoring documents, and train or coordinate CRAs.
Requirements
- Bachelor’s degree in life sciences, nursing, or a related field.
- At least 5–7 years of experience conducting on-site and remote monitoring visits, or equivalent clinical research experience.
- Broad therapeutic experience across multiple study types and indications, with a strong understanding of medical terminology.
- Advanced organizational, logistical, communication, stakeholder engagement, and problem-solving skills.
- Experience training, coaching, and mentoring clinical research staff.
- Proficiency with MS Office and EDC systems; willingness to travel up to 80%.
Nice to have
- Experience independently managing complex sites or overseeing complex sites and regions.
- Experience developing study-specific monitoring documents and driving process improvements.
Culture & Benefits
- Mission-driven work supporting safe and efficient access to clinical treatments.
- Remote work arrangement with extensive field travel for monitoring activities.
- Initiatives supporting wellness, professional growth, development, and team relationships.
- Inclusive, supportive environment focused on integrity, accountability, respect, and continuous growth.
Hiring process
- Submit an English-language resume through the careers portal or LinkedIn Easy Apply.
- An AI-supported Upwage screening step may be used before further interview stages.
- Selected candidates are contacted by the recruitment team for subsequent interview steps.
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