TMF Associate

Alimentiv

. Manage Trial Master File content and associated processes throughout the study lifecycle, from study setup to transfer/archiving .

Posted 11/6/2026full-timeWarsaw • PolandMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Trial Master File (TMF) management, ensuring completeness and inspection readiness throughout the study lifecycle. Proficient in applying ALCOA principles and managing electronic file repositories while providing training and mentorship to team members.

Highest-signal resume keywords

Trial Master File ManagementALCOA Principles ApplicationTMF Organization and ArchivalMicrosoft Office ProficiencyTime Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

TMF Completeness AssuranceDocument Review and ReconciliationQuality Control SchedulingFile Retrieval and ArchivingStudy-Specific Work Instructions Development

Soft Skills

Problem-Solving SkillsInitiativeMentorship AbilitiesCross-Functional Team Collaboration

Tools & Technologies

Electronic File Repository SystemsRecords-Management Systems

Industry Keywords

Clinical TrialsRegulatory ComplianceFile Structure ManagementInspection ReadinessDocument Management

About the role

Key responsibilities & impact

Manage Trial Master File content and associated processes throughout the study lifecycle, from study setup to transfer/archiving
Partner with study teams during periodic file reviews and audits to address TMF findings
Manage access and organization of the controlled electronic file repository according to defined file structure and access management framework
Serve as the primary TMF contact for assigned studies
Ensure TMF completeness and inspection readiness throughout the study lifecycle
Work with the Team Lead to create study-specific TMF management and oversight documents
Develop and maintain study-specific work instructions as needed
Maintain a quality control schedule and perform periodic TMF inventories
Review and communicate out-of-scope or incomplete documents, escalating as needed
Reconcile expected document lists based on study events and milestones
Prioritize and resolve TMF help desk tickets, including triage
Provide study-specific TMF training to internal and external stakeholders
Process and review documents using applicable scanning best practices and ALCOA principles
File and retrieve TMF documents in a timely manner
Complete routine administrative tasks such as timesheets and metrics
Participate in department meetings, presentations, and working groups
Assist with development, implementation, and maintenance of internal records-management systems
Provide mentorship and training to junior staff
Suggest and support improvements to department quality-system documents

Requirements

What you’ll need

College diploma/degree and 3 years of related experience or ongoing training
Understanding of TMF organization, implementation, and archival, including relevant regulations and guidance
Ability to incorporate ALCOA principles in relation to TMF oversight
Time management and problem-solving skills
Initiative to identify solutions to challenges and problems
Demonstrated computer literacy
Functional knowledge of Microsoft packages
Potential to develop
Ability to work proactively within a cross-functional team

Benefits

Comp & perks

Home based, with the ability to go into office occasionally if needed
Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle