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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, ensuring effective communication and independent follow-up on TMF-related activities.
Highest-signal resume keywords
Trial Master File (TMF) MaintenanceALCOA PrinciplesExcel ProficiencyQuality CheckingClinical 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 ProcessingTMF ReconciliationQuality ControlAudit Preparation
Soft Skills
Written CommunicationOral CommunicationIndependent Follow-UpResponsibility
Tools & Technologies
Internal Systems
Industry Keywords
Clinical ResearchSOPsCorrective and Preventative Action PlansProject 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 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 updates on TMF status
- Support preparation for study-specific audits
- Attend in-house project audits when required
- Participate in analysis of received audit reports
- Propose and oversee completion of Corrective and Preventative Action Plans for TMF aspects of projects
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 written and oral English communication skills
Benefits
Comp & perks- Remote work available
- Work-life balance
- Collaborative, international team environment
- Career growth opportunities
- Early ownership and responsibility
- Opportunity to make a meaningful impact by helping bring safe and effective pharmaceutical treatments to patients
- Collaborative team of experts in clinical research, pharmacovigilance, and quality consulting