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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 document processing, tracking, and reporting, ensuring compliance and readiness for audits.
Highest-signal resume keywords
TMF Maintenance ExperienceALCOA Principles KnowledgeExcel ProficiencyDocument Quality CheckClinical 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 MaintenanceDocument ProcessingQuality CheckALCOA PrinciplesReport Preparation
Soft Skills
Oral CommunicationWritten CommunicationResponsibility
Tools & Technologies
Internal Systems
Industry Keywords
Clinical ResearchSOPsAudit ParticipationCorrective Action PlansPreventative Action Plans
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 preparations for study-specific audits
- Attend in-house project audits when required and participate in analysis of audit reports
- Propose and oversee completion of Corrective and Preventative Action Plans for TMF aspects of projects
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
- Trusted ownership and responsibility
- Opportunity to make an impact through purposeful work
- Passionate and collaborative team of clinical research, pharmacovigilance, and quality consulting experts