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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in maintaining and quality-checking Trial Master Files (TMF) while adhering to ALCOA+ principles. Proficient in administrative tasks within an international Clinical Research environment, with strong communication skills in English.
Highest-signal resume keywords
Trial Master File (TMF) MaintenanceALCOA+ PrinciplesExcel ProficiencyQuality AssuranceClinical 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
Trial Master File (TMF) ManagementDocument ProcessingQuality CheckingAudit PreparationCorrective and Preventative Action Plans
Soft Skills
Independent Follow-UpCommunication Skills
Tools & Technologies
Internal Systems
Industry Keywords
Clinical ResearchSOPsProject ManagementStudy Audits
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 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 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- Experience maintaining and quality-checking Trial Master Files (TMF)
- Experience with ALCOA principles
- Administrative work experience, preferably in an international Clinical Research setting
- Proficiency in Excel
- Ability to take responsibility for TMF quality
- Ability to follow up on topics independently
- Very good English oral and written communication skills
Benefits
Comp & perks- Flexible/remote work arrangement (employees can work remotely)
- Work-life balance
- Career growth opportunities
- Collaborative international team environment
- Trusted ownership and opportunity to make an impact
- Supportive workplace culture
- Exposure to clinical research, pharmacovigilance, and quality consulting experts