Clinical Trial Associate

TL;DR

Clinical Trial Associate (Clinical Research): Maintaining and reviewing Trial Master Files (TMF) to ensure regulatory compliance for biotech and pharma companies with an accent on document quality and ALCOA+ standards. Focus on coordinating with clinical teams, performing completeness checks, and ensuring timely resolution of TMF queries.

Location: Remote based in Hungary (occasional office visits required, approximately once per month)

Company

hirify.global helps biotech, medtech, and specialty pharma companies transform science into new medicines, devices, and diagnostics.

What you will do

• Maintain Trial Master File (TMF) and electronic Trial Master File (eTMF) 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, and ALCOA+ standards.
• Perform completeness checks of eTMF sections during startup, maintenance, and close-out activities.
• Collaborate with internal clinical teams to resolve TMF queries in a timely manner.
• Generate and distribute eTMF reports to ensure overall quality and compliance.

Requirements

• Undergraduate degree in nursing, life sciences, or medical documentation.
• 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 Hungary.

Culture & Benefits

• Focus on professional growth, skill development, and opportunities to excel.
• Flexible work environment that supports work-life balance.
• Collaborative culture where employee ideas influence operational workflows.
• Opportunity to contribute to delivering critical medical innovations to patients.