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2018-44729

2018-44729

Title 
TMF Coordinator - Boston MA
Job Locations 
-
US-MA-Boston
Posted Date 
2/16/2018

More information about this job

Overview

As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.

 

At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

 

At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.

 

Responsibilities

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.

Qualifications

 

REQUIRED EXPERIENCE:

  • Proficienworking within a Microsoft Office Environment
  • Independent time management and problem-solving
  • Industry knowledge including ICH/GCP, local regulatory authority and clinical development regulations
  • Prioexperience using computerized information systems
  • Prioexperience in a leadership role
  • Proficient in developing project/process documents
  • Read, write and speak fluent English; fluent in host country language required
  • Some college coursework

PREFERRED EXPERIENCE:

 

  • 0-3 years of Clinical, Quality, or Information Management experience
  • Possess some general knowledge of clinical trials and basic principles, procedures, and common best practices
  • Strong command of Microsoft Office Suite
  • Demonstrates basic knowledge and understanding of applicable regulations
  • Demonstrates effective, self-sufficient communication skills
  • Displays good interpersonal skills and ability to deal with a variety of personnel 
  • Undergraduatdegree



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

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