Associate I – TMF Operations

Lifelancer

Associate I at Worldwide Clinical Trials responsible for TMF operations including document processing and compliance. Engaging with global project teams to uphold clinical research quality.

Posted 7/8/2026full-timeRemote • 🇷🇴 RomaniaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates proficiency in Trial Master File (TMF) management, including processing and reviewing documents in compliance with regulatory standards. Possesses strong communication skills and the ability to work collaboratively within a regulated environment.

Highest-signal resume keywords

TMF ManagementElectronic Document ManagementMicrosoft Word ProficiencyMicrosoft Excel ProficiencyClinical Research Principles

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

TMF ExperienceData Collection SkillsIndexing SkillsEditing SkillsDocument Naming Conventions

Soft Skills

Excellent Written CommunicationExcellent Verbal CommunicationSound Judgment

Tools & Technologies

Electronic TMF SystemsDocument RepositorySharePoint

Industry Keywords

CROPharmaRegulated IndustryClinical Research

About the role

Key responsibilities & impact

Fulfil the "TMF Approver" role as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.
Process, review, and resolve rejected Trial Master File (TMF) documents, for multiple studies both in an electronic and hard copy format.
Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
Escalate any TMF Quality issues in a timely manner to RMC Lead.
Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
Perform additional tasks as assigned by their Line Manager.

Requirements

What you’ll need

University Degree preferred
Minimum 6 months of relevant TMF experience
Knowledge of working within a highly regulated industry (preferably within CRO/Pharma industries)
Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions.
Possess excellent written and verbal communication skills to clearly and concisely present information.
Work with internal teams and can execute tasks under general direction, seeks assistance as needed.
Exercise sound judgment and ability to identify decisions requiring supervisory approval.
Demonstrate proficiency in Microsoft Word and Excel.
Develop proficiency in use of an electronic document repository or eTMF, and document recognition skills.
General understanding of clinical research principles and processes.

Benefits

Comp & perks

Competitive salary
Flexible working hours
Professional development budget
Home office setup allowance
Global team events