Tmf Specialist - Hybrid (bulgaria, Slovakia)

IQVIA UK

Bulgaria
Trial master file (tmf) expertise
Records management expertise
Ich and gcp knowledge
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.

Skills & Requirements

Must-have

  • Trial Master File (TMF) expertise
  • Records Management expertise
  • ICH and GCP knowledge
  • Monitoring filing accuracy
  • Ensuring inspection readiness

Nice-to-have

  • Ability to lead others
  • Client relationship management
  • Strategic planning assistance

Key Requirements

  • High School Diploma or equivalent
  • 3 years of Records Management experience
  • Knowledge of applicable regulatory requirements
  • Ability to handle multiple tasks
  • Excellent oral and written communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter