Clinical Trial Associate (Medtech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Clinical Trial Associate (Medtech): Managing Trial Master Files (TMF/eTMF) and ensuring regulatory compliance for biotech and pharma companies with an accent on document verification and quality control. Focus on maintaining eTMF completeness, reviewing site documentation against ALCOAC standards, and coordinating with clinical teams for timely query resolution.
Location: Remote based in Czech Republic (occasional office visits required, e.g., once per month)
Company
is a clinical research organization helping biotech, medtech, and specialty pharma companies transform science into new medicines and diagnostics.
What you will do
- Maintain Trial Master Files (TMF/eTMF) in collaboration with clinical teams according to SOPs and regulatory requirements.
- Create and manage TMF placeholders based on filing plans, study milestones, and site staff changes.
- Review site documents to verify they meet company, sponsor, regulatory authority, and ALCOAC standards.
- Perform completeness checks of eTMF sections throughout startup, maintenance, and close-out activities.
- Generate and distribute eTMF reports to the clinical team to ensure quality and compliance.
- Assist SSUAs/CRAs with essential document collection and support the translation of site documents.
Requirements
- Undergraduate degree in nursing, life sciences, or medical documentation from an accredited institution.
- Minimum 1 year of prior experience as a Clinical Trial Associate or in a similar role.
- Fluent verbal and written English.
- Working knowledge of ICH/GCP, essential documents, and ALCOA+ principles.
- Must be based in the Czech Republic to accommodate occasional office visits.
Culture & Benefits
- Support for professional growth with opportunities to develop new skills.
- Work flexibility and balance to support personal life requirements.
- Collaborative culture where employee ideas influence operational processes.
- Opportunity to contribute to medical innovations that save and improve lives.
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