TMF Analyst in Bulgaria

Job Purpose

Responsible for management of expected Trial Master Files (TMF) structure and records in the eTMF system, in compliance with applicable SOPs, processes and established timelines. Supports the goal to have well managed and effective clinical trials teams, through standardization and process improvements for assigned activities.

Main Duties

• eTMF table of content / file plan for documents applicability
• Maintenance of the expected number of documents per eTMF file structure:
  • Support for management of signposts
  • Support TMF manager with the TMF quality and completeness review
  • Ensures queries and corrective actions are properly documented
  • Review of CSR appendices and availability of CSR essential documents
  • eCTD (electronic common technical document) tracker
  • End of trial checklist
  • Full protocol package support
• Provide support to Clinical Trial Teams (CTT) for system access requests, trial creation, access to training material
• Provide input on queries from technical QC
• Support resolution of issues in collaboration with other roles/teams in Clinical Document Governance and Management (CDGM) and follow through to resolution and escalate effectively as needed to ensure that identified issues are addressed
• Support TMF inspection readiness activities for TMF as needed for the assigned trials
• Collaborate with other CDGM team in the creation of training material and job aids
• Assigned to multiple studies/CTTs

Key Performance Indicators:

• Mainly as defined by the line function / clinical document support group for assigned activities
• Timely and high-quality provision of assigned tasks per document management standards
• Consistent use of electronic DMS and adherence to paper processes in line organizations
• Strong collaboration with TMF managers and assigned CTTs as well as other line functions

Ideal Background:

• Strong knowledge of clinical Trial Master File process/activities and Good Clinical Practice
• Knowledge of applicable research and regulatory environments, i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP)
• Excellent knowledge of clinical documentation and reporting
• Good understanding of technical processes and PC environment including Microsoft suite of products
• Knowledge of the national and international data protection legislation
• Demonstratable ability to work both independently and in team settings
• Experience with project work in a global, cross-functional multicultural and international matrix organization
• Ability to handle multiple tasks and projects within defined timelines and balance competing priorities
• Excellent communication, organization and tracking skills

Education:

• Bachelor’s degree in life science/healthcare is required; and/or minimum 2 years’ experience with document management systems or records management environment and excellent understanding of system structures and generic document management functionality
• Fluent written and oral English

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.