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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Trial Master File (TMF) management, including maintenance, quality checks, and adherence to ALCOA+ principles. Proficient in administrative tasks within a clinical research environment, with strong communication skills in English.
Highest-signal resume keywords
TMF Maintenance ExperienceALCOA Principles KnowledgeExcel ProficiencyQuality Check ResponsibilityClinical Research Administrative Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
TMF ManagementDocument ProcessingQuality CheckingAudit PreparationCorrective Action Planning
Soft Skills
Communication SkillsResponsibilityIndependence
Tools & Technologies
Internal Systems
Industry Keywords
Clinical ResearchTrial Master FileSOPsProject DocumentationAudit Analysis
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 for 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 when agreed and prepare the TMF for archiving
- Track and quality-check documents using internal systems and ALCOA+ principles
- Prepare study team reports or TMF status updates
- Support study-specific audit preparations
- Attend in-house project audits when required and participate in analysis of audit reports
- For TMF Specialist II, 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 and follow up on topics independently
- Very good English oral and written communication skills
Benefits
Comp & perks- Remote work option
- Work-life balance
- Collaborative, international team environment
- Career growth opportunities
- Trusted ownership and flexibility
- Opportunity to work with experts in clinical research, pharmacovigilance, and quality consulting