Clinical Project Manager

Synageva BioPharma


July 2, 2014

JOB TITLE: Clinical Project Manager

REPORTING RELATIONSHIP: Associate Director, Clinical Operations


LOCATION: Lexington, MA


The Clinical Project Manager (CPM) will be responsible for the hands-on management of early and late-stage clinical studies:

  • Drive activities internally and externally to ensure timely and successful execution for clinical trial activities.
  • Manage all logistical and operational activities for the clinical trial(s) including internal and external project team oversight.
  • In conjunction with Clinical Project Associate(s), oversee:
    • Trail Master File (TMF) maintenance
    • Essential document collection for IRB/EC and country submissions, and investigational medicinal product (IMP) release to study sites
    • Study progress and issues (site qualification through close-out)
    • Monitoring visit and report status
    • Safety Report preparation and dissemination
    • Clinical data activities
  • Oversee the tracking and communication of overall study status – including maintenance of current, complete and accurate status reports.
  • Development and review of key study documents including: study manuals, training materials, tools, and templates.
  • Maintain current, complete and accurate budgets, IMP and study supply forecasts.
  • Ensure inspection readiness in compliance with company processes and regulatory requirements.
  • Prepare and manage detailed project plan in MS Project.
  • Assist with the preparation and presentation at investigator meetings as required to ensure that the clinical and investigational site staff team is well informed about the study and related procedures.


  • Educated to degree level (biological science, pharmacy, or other health related discipline preferred) or equivalent nursing qualification/experience.
  • Minimum 3-5 years of industry experience within clinical research/operations.
  • Experience managing global clinical trials in rare diseases with orphan drug designation is a plus.
  • Excellent interpersonal, verbal and written communication skills (including presentation skills).
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
  • Able to take initiative and work independently with sense of urgency in completing assigned tasks.
  • Flexibility towards work assignments, new learning and travel (overnight, weekend and international travel may be required).  Flexibility to accommodate travel up to 30%.
  • Team player with outstanding negotiation skills and organizational skills.
  • Computer Proficiency: MS Office suite and working knowledge of MS Project required.

Apply Now

  • Company Synageva BioPharma
  • Contact Name
  • Position Location Lexington, MA
  • Minimum Required Education Bachelor's Degree
  • Minimum Preferred Education Bachelor's Degree
  • Minimum Years Experience 3
  • Career Level Experienced Non-manager
  • Size of Company in MA 170
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