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2017-42564

2017-42564

Title 
TMF Coordinator
Job Locations 
-
US-KS-Lenexa
Posted Date 
1/12/2018

More information about this job

Overview

The Trial Master File (TMF) Coordinator is responsible for collecting, developing and documenting the requirements for the TMF. To coordinate, monitor and report on key TMF activities of the project team and other Document Management staff, including TMF Readiness Reviews and final delivery of the TMF. Provides project-specific oversight and training to other Document Management staff and serves as the main Document Management contact for internal and external customers.

Responsibilities

  • Liaises with internal and external customers to meet project specific goals for the Trial Master File and prepares the TMF Specifications to document the objectives and requirements
  • Identifies out of scope tasks and determines associated effort and actions for complex project needs
  • Interacts with sponsors, PRA functional areas and if applicable, document management vendors, for project-related issues, needs and tasks
  • Configures checklists within the eTMF system to support the TMF Specifications and maintaining global level events
  • Coordinates TMF Readiness Reviews and facilitates accurate and timely completion of deficiencies
  • Participates in audits and presents on services related to functional area for assigned projects; coordinates and hosts sponsor on-site TMF reviews, if required
  • Monitors project team and Document Management compliance to routine TMF activities
  • Ensures accurate set-up, maintenance, delivery and archiving of project files by providing oversight and training of these project-specific activities to other Document Management staff
  • Reports and analyzes key performance indicators to support:
o      Project Managers with providing a complete, timely and quality TMF deliverable
o      The TMF process owner to ensure TMF processes are efficient, effective and meeting QMS standards
  • Coordinates end of study delivery and archiving of the project files

Qualifications

Minimum Qualifications

  • Proficient working within a Microsoft Office Environment
  • Independent time management and problem-solving
  • Industry knowledge including ICH/GCP, local regulatory authority and clinical development regulations
  • Prior experience using computerized information systems
  • Prior experience in a leadership role
  • Read, write and speak fluent English; fluent in host country language required

 

Preferred 

  • Undergraduate degree





PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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