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Associate Clinical Trials Manager

Vertex Pharmaceuticals


Location:
Boston, Massachusetts
Date:
08/30/2018
2018-08-302018-09-29
Categories:
  • Clinical Operations
Vertex Pharmaceuticals
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Job Details

Job Description:


The Associate Clinical Trials Manager is responsible for independently managing Trial Master Files for assigned studies. The Associate Clinical Trials Manager will participate in end-to-end TMF management activities, including but not limited to: TMF planning, setup, adherence to organizational TMF standards and study-level quality control reviews and facilitating issue resolution.
KEY RESPONSIBILITIES:

  • Ensure TMF completeness and accuracy based on Vertex SOPs and regulatory requirements.
  • Provide oversight of TMF documentation and QC in accordance with Good Documentation Practice, Good Clinical Practice
  • Possess good critical thinking skills with a focus on inspection readiness.
  • Conduct content review of a variety of documents in a short time frame while maintaining consistency and attention to detail.
  • Prioritize work accordingly to meet departmental needs and work toward and meet deadlines with some supervision.
  • Generates metrics for study team consumption supporting TMF completeness and accuracy
  • Participate in inspection readiness reviews and preparations

TECHNICAL AND COMMUNICATIVE SKILLS:

  • Proficiency in relevant eTMF systems and programs
  • Displays sound project management skills to independently manage TMF projects with some supervision
  • Demonstrates ability to communicate and coordinate activities within the group and all TMF Stakeholders
  • Able to proactively identify project challenges/risks and implement appropriate actions with some supervision
  • Strong communication (written and verbal) skills
  • Emerging vendor management skills
  • Demonstrated computer literacy; proven functional knowledge of Microsoft packages and ability to develop

 

Qualification:


M.S. (or equivalent experience) and 2- years of relevant work experience
B.S. (or equivalent experience) and 3-6 years of relevant work experience

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