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TMF Associate
TFS HealthScience - Contract Research Organization. Establish and maintain Trial Master Files (TMFs) according to company procedures and regulatory requirements .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Trial Master Files (TMFs) and Investigator Site Files (ISFs) while ensuring compliance with ICH-GCP guidelines. Proficient in document quality control, training study teams, and preparing status reports to maintain audit readiness throughout the study lifecycle.
Highest-signal resume keywords
Trial Master File ManagementICH-GCP Guidelines KnowledgeDocument Quality ControlOrganizational SkillsCommunication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Trial Master File ManagementDocument Quality ControlTMF Metrics MonitoringTMF ReconciliationStudy-Specific TMF Plans DevelopmentInvestigator Site Files ManagementRegulatory ComplianceQuality Improvement InitiativesTraining DevelopmentAudit Preparation
Soft Skills
Strong Organizational SkillsMultitasking SkillsKeen Attention to DetailExcellent Written CommunicationExcellent Verbal Communication
Industry Keywords
Health SciencesDocument ManagementRegulatory RequirementsQuality ControlCompliance IssuesStudy LifecycleSubmission ReadyInspection ReadyAudit ReadyTMF Training
About the role
Key responsibilities & impact- Establish and maintain Trial Master Files (TMFs) according to company procedures and regulatory requirements
- Develop and maintain study-specific TMF Plans
- Provide TMF-related training to study teams
- Perform document quality control reviews and reconciliation activities
- Monitor TMF metrics and identify quality or compliance issues
- Drive resolution activities for quality or compliance issues
- Prepare and distribute monthly TMF status reports to project and functional leadership
- Coordinate TMF reconciliation activities and support document transfers to sponsors
- Ensure TMFs remain submission-, inspection-, and audit-ready throughout the study lifecycle
- Serve as the primary TMF contact for study teams
- Participate in study team meetings and provide updates on TMF quality and status
- Support audits, inspections, and quality improvement initiatives
- Set up and maintain Investigator Site Files (ISFs) when required
Requirements
What you’ll need- Bachelor's degree in Health Sciences, Document Management, or a related field, or equivalent work experience
- 1–2 years of experience working with TMF
- Knowledge of ICH-GCP guidelines and TMF requirements
- Strong organizational and multitasking skills
- Keen attention to detail
- Excellent written and verbal communication skills
- Home-based in Poland
Benefits
Comp & perks- Competitive compensation package
- Comprehensive benefits
- Opportunity for personal and professional growth
- Collaborative and innovative work environment
- Home-based/fully remote work arrangement