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Principal Clinical Trials Manager

Reference Number: 3915
Location: MA

Our client is a global biotechnology company. They have asked us to assist them in their search for a Principal Clinical Trials Manager.

Major tasks and responsibilities will include:

  • Develops and implements complex study plans in one or more clinical studies with minimal supervision.
  • Provides oversight of all Clinical Operations staff supporting projects.
  • Drafts plans for multiple related studies with oversight
  • Develops study budget(s) with oversight.
  • Attends scientific meetings and builds relationships with Investigators and 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 pre-qualification of clinical sites.
  • Ensures external and internal documentation prepared within the Clinical Operations function is completed in compliance with regulatory requirements and consistent with the protocol.
  • May represent Clinical Operations on Clinical Development Team(s) and contribute to Clinical Development Plans with some oversight.
  • Manages team and individual performance appropriately.
  • May supervise other clinical staff.
  • Performs other duties as assigned.

We seek candidates with the following qualifications:

  • Bachelor’s degree required. Master’s degree highly preferred.
  • Must have a minimum of 6 years of relevant experience in the pharmaceutical industry.
  • The incumbent must possess highly developed project leadership skills.
  • Must be an expert on assigned protocols with deep understanding of Clinical Operations and Drug Development.
  • The demonstrated ability to integrate and summarize medical/scientific concepts in protocols and other documents is required.
  • Requires a proven track record of anticipating potential study issues and preparing contingency plans with minimal oversight.

If interested, please email your resume as a Word attachment to us, reference 3915.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.