Trial Master File Specialist (TMFS) II - TMF and ALCOA principles experience required

Added
16 days ago
Type
Full time
Salary
Salary not provided

Related skills

excel clinical research tmf

📋 Description

  • Assists with set up and maintenance of the Trial Master File (TMF).
  • Serves as main point of contact for all TMF-related activities for assigned projects.
  • Processing and indexing of project documents for the TMF in accordance with project-specific
  • Upon study closure, assists in reconciliation of TMF; ships files to client, if agreed, and
  • Tracks and performs quality check of documents using internal systems and ALCOA+ principles.
  • Prepares study team reports or updates regarding status of TMF as required.

🎯 Requirements

  • TMF maintenance and quality check experience
  • ALCOA Principles
  • Administrative work experience, preferably in an international Clinical Research setting
  • Proficiency in Excel
  • Ability to take over responsibility for TMF quality; follow up on topics independently
  • Very good English oral and written communication skills
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