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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 preparing for audits and managing project documentation in compliance with clinical research standards.
Highest-signal resume keywords
TMF Maintenance ExperienceALCOA Principles KnowledgeExcel ProficiencyClinical Research Administrative ExperienceEnglish Communication 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
TMF ManagementDocument IndexingQuality CheckAudit PreparationCorrective Action Plans
Soft Skills
Independent Follow-UpResponsibility Taking
Tools & Technologies
Internal Systems
Industry Keywords
Clinical ResearchSOPsTrial Master FileProject Documentation
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 when agreed
- 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 preparation for study-specific audits
- Attend in-house project audits when required
- Participate in analysis of received 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 over responsibility for TMF quality
- Ability to 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 autonomy
- Passionate and collaborative team of experts
- Diverse and inclusive workplace where every voice counts