TMF Manager in Poland
Warsaw, Poland
‎20 godz. temu

Job Purpose

Responsible for efficient and appropriate management of Trial Master Files (TMF) and other TMF related, inspection relevant documents from creation through archival in compliance with applicable SOPs, processes and study specific requirements for assigned trials according to established timelines.

Main Duties

  • Drive TMF Quality at trial level : Act as SPOC and business partner for CTT and TMO : collect and understand requests, work on with other roles / teams in CDGM and follow through to resolutionProvide subject matter expertise, ensures compliance with TMF processes and tools and promotes awareness of the importance of a high quality TMFSupport the definition and refinement of the document management strategy for TMFs within each assigned Clinical Trial Team (CTT)Promote best documentation practice to line functions and provide guidance on document standards for the business functions to support inspection readiness and adherence to Good Documentation Practice
  • Responsible for TMF Quality & completeness review : Review TMF quality early and during the study, with targeted and risk based approachIdentify & communicate gaps completeness and quality gaps throughout the studyUnderstand specific study risks and how they translate into TMF risks (e.
  • g. Issue on data integrity)

  • Communicate gaps to LF, identify corrective actions, track completion and escalate effectively as needed to ensure that identified issues are addressed by LFs
  • Identify and communicates trends / risks based on review at project level, and aligns across projects for consistency
  • Oversee the process, system and tool landscape that supports the management of TMFs
  • Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs
  • Drive TMF inspection readiness activities for TMF as needed for the assigned trials
  • Responsible for definition of applicability and number of expected documents in the eTMF systems, and TMF management plan (if applicable)
  • Provide input on queries from Technical QC, and seeks LF input
  • Assigned to several Trials / CTTs
  • Key Performance Indicators :

  • Inspection ready submission relevant documentation - no critical audit or inspection findings on formal TMF document compliance aspects (paper and electronic documentation)
  • Timeliness of TMF review, per key milestones as per process
  • Completeness of TMF review, including document availability, signposts
  • Timely and high-quality provision of new or updated document management standards and guidance documents
  • Consistent use of electronic DMS and adherence to paper processes in line organizations
  • Smooth and timely implementation of a new DMS production environment addressing business benefits
  • Effective and efficient leadership of improvements and innovation initiatives
  • Ideal Background :

  • Thorough knowledge of clinical Trial Master File process / activities, regulatory requirements and Good Clinical Practice
  • Advanced knowledge of clinical documentation and reporting
  • Knowledge of applicable research and regulatory environments, i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP)
  • Good understanding of technical processes and PC environment including Microsoft suite of products
  • Knowledge of the national and international data protection legislation
  • Advanced ability to work both independently and in matrix team setting
  • Experience with project work or project management 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; with minimum 5 years’ experience in clinical development / clinical operations and minimum 3 years’ experience with document management systems and excellent understanding of system structures and generic document management functionality
  • Fluent written and oral English
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