18 дней назад
Real-World Data Specialist (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Real-World Data Specialist (MedTech): Planning and executing real-world data collection for Expanded Access Programs and non-interventional studies with an accent on data quality, regulatory compliance, and stakeholder coordination. Focus on monitoring data completion, resolving discrepancies, and improving SOPs, templates, workflows, and supporting tools.
Location: Hybrid, Amsterdam HQ
Company
is a global health tech company developing an AI-powered platform and specialized services to improve access to treatments in development.
What you will do
- Lead the planning and execution of real-world data collection within Expanded Access Programs and non-interventional studies.
- Coordinate communications with clients, physicians, site staff, and internal teams to support effective data collection.
- Monitor data completion and quality, identify discrepancies and risks, and coordinate timely resolution.
- Ensure real-world data collection complies with ICH-GCP and relevant regulatory guidelines.
- Maintain and improve SOPs, templates, documentation, workflows, and supporting tools.
- Collaborate with Clinical Operations, Data Management, Commercial, and client teams to align deliverables with program goals.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
- At least 2 years of experience in Data Management, real-world data, or Clinical Research.
- Familiarity with electronic data capture systems and strong proficiency in Microsoft Office Suite.
- Understanding of ICH-GCP guidelines; certification is preferred.
- Strong organizational, problem-solving, communication, and attention-to-detail skills.
- Proactive, team-oriented approach and experience working with site and client stakeholders.
Culture & Benefits
- Impactful work supporting patient access to potentially lifesaving treatments.
- International work environment with a flat organizational structure and scale-up environment.
- Competitive salary, annual performance bonus, and Employee Stock Option Plan.
- Learning and development budget, internal knowledge-sharing sessions, and career development opportunities.
- Attractive pension plan with the full premium covered, parent-support policies, and healthy lunch at the Amsterdam office.
- Professional psychological guidance, monthly culture events, and an annual company-wide celebration.
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