eTMF Specialist
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
eTMF Specialist: Maintaining the electronic Trial Master File (eTMF) and ensuring accurate filing of study documentation with an accent on quality control and regulatory compliance. Focus on managing document lifecycles, supporting study teams, and ensuring inspection-readiness of clinical trial records.
Location: Must be based in the Philippines
Company
is a full-service, science-driven CRO founded in 1998, providing premium trial management and innovative IT solutions for multi-country clinical trials.
What you will do
- Review study documents for quality, completeness, and compliance before filing.
- Upload, index, and maintain documentation within the eTMF system.
- Act as the primary point of contact for study teams regarding document filing and archiving.
- Manage both electronic and physical documentation, including scanning and archiving.
- Ensure the eTMF is accurate, up-to-date, and inspection-ready at all times.
- Resolve documentation issues and address Sponsor queries.
Requirements
- Must be based in the Philippines
- College Degree
- At least one year of experience in the pharmaceutical, biotechnology, or CRO industry
- Familiarity with document management systems and electronic databases
- Good knowledge of English (written and speaking)
- Proficiency in Microsoft Office
Culture & Benefits
- Opportunity to work with a specialized, science-driven international team.
- Exposure to complex, multi-country clinical trial management.
- Fully remote work arrangement.
- Professional development in a regulated industry environment.
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