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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) maintenance, quality checks, and adherence to ALCOA+ principles, with strong administrative skills in a clinical research environment. Proficient in preparing reports and managing TMF-related activities while ensuring compliance with project-specific guidelines.
Highest-signal resume keywords
TMF Maintenance ExperienceALCOA Principles KnowledgeExcel ProficiencyEnglish Communication SkillsClinical Research 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 MaintenanceDocument Quality CheckTMF ReconciliationProject Document IndexingCorrective and Preventative Action Plans
Soft Skills
ResponsibilityIndependenceAttention to Detail
Tools & Technologies
Internal Systems
Industry Keywords
Clinical ResearchSOPsStudy AuditsTrial Master FileProject Management
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 updates on TMF status
- Support preparation for study-specific audits
- 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 project TMF aspects
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 availability
- Work-life balance
- Collaborative, international team environment
- Career growth opportunities
- Opportunity to take ownership early
- Passionate and collaborative team of clinical research, pharmacovigilance, and quality consulting experts