Trial Master File Specialist II – TMF, ALCOA Principles

ERGOMED

. Assist with setup and maintenance of the Trial Master File (TMF) .

Posted 10/15/2026full-timeRemote • Bosnia & HerzegovinaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Trial Master File (TMF) maintenance, quality checks, and adherence to ALCOA+ principles, with strong administrative skills in a Clinical Research environment. Proficient in document tracking, reporting, and supporting audit preparations while ensuring compliance with project-specific guidelines.

Highest-signal resume keywords

TMF Maintenance ExperienceALCOA Principles ExpertiseExcel ProficiencyQuality Check ResponsibilityEnglish Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

TMF MaintenanceDocument IndexingQuality CheckAudit PreparationCorrective Action PlansPreventative Action Plans

Soft Skills

Independent Follow-UpResponsibility

Tools & Technologies

Internal Systems

Industry Keywords

Clinical ResearchSOPsTrial Master FileProject-Specific Guidelines

About the role

Key responsibilities & impact

Assist with setup and maintenance of the Trial Master File (TMF)
Serve as the main point of contact for TMF-related activities on assigned projects
Process and index project documents in the TMF according to project-specific guidelines and relevant SOPs
Assist with TMF reconciliation upon study closure
Ship files to the client, if agreed, and prepare the TMF for archiving
Track and quality-check documents using internal systems and ALCOA+ principles
Prepare study team reports or updates regarding TMF status
Support preparations for study-specific audits
Attend in-house project audits when required
Participate in analysis of received audit reports
Propose and oversee completion of Corrective and Preventative Action Plans for TMF aspects of the project

Requirements

What you’ll need

TMF maintenance and quality check experience
Experience with ALCOA Principles
Administrative work experience, preferably in an international Clinical Research setting
Proficiency in Excel
Ability to take responsibility for TMF quality
Ability to follow up on topics independently
Very good English oral and written communication skills

Benefits

Comp & perks

Remote work availability
Work-life balance
Career growth opportunities
Collaborative international team environment
Opportunity to make an impact on patient care
Supportive workplace culture
Passionate and collaborative team of experts
Belonging and inclusive environment