Tmf Specialist - Hybrid (poland)

IQVIA

Warsaw, Poland
Base: zł80,500.00 - zł190,900.00; bonus/equity: no...
Trial master file (tmf) expertise
Records management expertise
Ich gcp applicable requirements
Serve as the liaison between Records Management and user departments regarding Trial Master Files (TMF), applying Records Management expertise to provide project-related assistance across complex and multiple projects

Job Summary

  • Serve as the liaison between Records Management and user departments regarding Trial Master Files (TMF), applying Records Management expertise to provide project-related assistance across complex and multiple projects.
  • Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics.
  • The role involves comprehensive TMF review including crosscheck and co-dependency checks to ensure inspection readiness of TMF.

Matching Summary

Serve as the liaison between Records Management and user departments regarding Trial Master Files (TMF), applying Records Management expertise to provide project-related assistance across complex and multiple projects.

Salary

Base: zł80,500.00 - zł190,900.00; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Trial Master File (TMF) expertise
  • Records Management expertise
  • ICH GCP applicable requirements
  • Quality and timeline metrics
  • Inspection readiness of TMF

Nice-to-have

  • Ability to lead others
  • Client relationship management
  • Strategic goal implementation

Key Requirements

  • High School Diploma or equivalent
  • 3 years of Records Management experience
  • Knowledge of ICH GCP and local regulations
  • Knowledge of records management technology
  • Ability to handle multiple tasks and projects

Work Rights

Not specified

Tailored Resume

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