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Clinical Trial Management Principal
at Vertex Pharmaceuticals
Boston, MA

Clinical Trial Management Principal
at Vertex Pharmaceuticals
Boston, MA

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Description

The Principal Clinical Trials Manager is responsible for the planning, implementation and conduct of large, complex clinical trials or multiple smaller studies across indications or development compound(s). The Principal Clinical Trials Manager is expected to provide leadership within the department and to make recommendations with regards to the strategic aspects of Clinical Operations deliverables.

KEY RESPONSIBILITIES:

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

  • Able to develop and execute complex study plans in one or more clinical studies with minimal supervision
  • Provides oversight and integration activities of all Clinical Operations staff supporting assigned projects
  • Able to draft plans for multiple related studies, with oversight
  • Develops study budget(s) with oversight
  • Attends scientific meetings and builds relationships with Investigators, business partners
  • Participates in study data review and interpretation
  • Participates in and contributes to publication strategy and content
  • Assumes a lead role in the identification process of Investigators or vendors and assures proper prequalification of clinical sites
  • Ensures external and internal documentation prepared within the Clinical Operations function is completed in accordance with GCP regulatory requirements and consistent with the protocol, for all assigned programs/trials
  • May represent Clinical Operations on Clinical Development Team(s)
  • Manages team and individual performance appropriately
  • May supervise other clinical staff
  • Performs other duties as assigned
  • Displays highly developed project leadership qualities
  • Deep understanding of Clinical Operations and Drug Development. Expert on assigned protocols
  • Demonstrates ability to integrate and summarize medical/scientific concepts in protocols and other documents
  • Proactively seeks out and recommends process improvements
  • Proven track record of anticipating potential study issues and preparing contingency plans with minimal oversight
  • Communicates clearly and effectively with internal and external key stakeholders
  • Routinely mentors and may supervise junior staff. Takes a leadership role in on boarding new personnel
  • May contribute to Clinical Development Plans with some oversight
  • Consistently demonstrates overall leadership in Clinical Operations

PREFERRED EDUCATION AND EXPERIENCE:

  • M.S. (or equivalent experience) and 6+ years of relevant work experience
  • B.S. (or equivalent experience) and 8+ years of relevant work experience

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