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Clinical Project Manager

Vertex Pharmaceuticals


Location:
Boston, Massachusetts
Date:
05/10/2017
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
Vertex Pharmaceuticals
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Job Details

Job Description

The Clinical Project Manager responsible for independently managing multiple clinical studies of moderate complexity or managing a broader range of activities on large multi-center studies. The Clinical Project Manager is expected to address site and vendor related issues, with assistance as needed. 

Key Responsibilities:

Advance those of the Clinical Trials Manager to include the following:

  • Responsible for managing approved study budget(s)
  • Develops and oversees study operational plan(s)
  • Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical studies
  • Assists with protocol design and strategy and medical issue resolution
  • Participates in study data review and assists with patient narrative writing and other data review activities as assigned
  • Contributes significantly to relevant study documentation including clinical protocols, statistical analysis plan, and clinical study reports
  • Proactively identifies project risks and resolves with some supervision
  • Participates in the selection of Investigators and vendors
  • May mentor more junior Clinical Operations Staff or participate in the onboarding of new personnel
  • Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team
  • Ensures assigned studies adhere to all applicable regulations and requirements relevant to the study phase, design and/or use of data.
  • Performs other duties as assigned
Technical and Communicative Skills:

In addition to the attributes of a Clinical Trials Manager:
  • Strong study management track record showing clear proficiency in clinical project management skills.
  • Solid vendor management skills
  • Broad understanding of operations including those in related development functions
  • Demonstrates detailed understanding of clinical protocol , intended study populations as well as solid overall drug development
  • Demonstrates ability to effectively interface with key medical personnel at clinical site(s)
  • Demonstrates ability to lead multi-disciplinary teams
  • Demonstrates ability to flag processes that may not be appropriate for study based on phase, design, and/or use of data
  • Maintains a flexible, can-do approach to address issues proactively and innovatively
  • Possesses excellent written and oral communications skills

 

Minimum Qualifications

M.S. (or equivalent experience) and 4+ years of relevant work experience
B.S. (or equivalent experience) and 6+ years of relevant work experience

Company Information

 

Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases. 

Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For four years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com. 

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

 

Req ID

9154BR