TMF Manager, Sponsor-Dedicated

2 tygodni temu


Warszawa, Mazovia, Polska IQVIA Pełny etat

Job Purpose: Responsible for managing Trial Master Files (TMF) and other TMF-related documents for assigned trials, ensuring compliance and quality.

Main Duties:

  • Drive TMF Quality at trial level, acting as a SPOC and business partner
  • Review TMF quality and completeness
  • Communicate gaps and identify corrective actions
  • Oversee the process, system, and tool landscape supporting TMFs
  • Ensure deliverables comply with guidelines and internal processes
  • Drive TMF inspection readiness activities
  • Provide input on queries and seek LF input
  • Assigned to several Trials/CTTs

Key Performance Indicators:

  • Inspection ready submission of relevant documentation
  • Timeliness and completeness of TMF review
  • Provision of document management standards and guidance
  • Use of electronic DMS and improvement initiatives

Ideal Background:

  • Thorough knowledge of clinical Trial Master File process
  • Advanced knowledge of clinical documentation and reporting
  • Good understanding of regulatory environments and data protection legislation
  • Ability to work independently and in a matrix team setting
  • Experience in project management in a global organization
  • Excellent communication, organization, and tracking skills
  • Minimum 6 years of experience with document management systems

Education:

  • Bachelor's degree in life science/healthcare
  • Fluent in written and oral English

IQVIA is a global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, committed to making a positive impact in healthcare. Learn more at IQVIA.com



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