Connecting...

Senior Clinical Project Manager

Location: Cambridge Salary: competitive
Sector: Pharma & Biotech, Medical Devices, Clinical Research, R&D, Operations, Operations, R&D Type: Contract

Senior Clinical Project Manager (Clinical Operations) - Cambridge, MA

Our client, a mid-sized pharmaceutical company in Cambridge, is looking for a Senior Clinical Project Manager to help with phase II and III Rare Disease trials. This is an exciting opportunity for an experienced clinical project manager, who is looking to work with cutting edge technology and leading professionals within the industry.

Senior Clinical Project Manager (Clinical Operations) - Cambridge, MA

Primary Duties:

  • Serve as point of contact for key vendors and stakeholders
  • Manage cross functional teams to ensure a high quality clinical trial(s)
  • Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages
  • Participate in program strategy meetings, ad hoc clinical operations' initiatives and programs.
  • Ensures that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct
  • Monitors the status of clinical data collection of assigned clinical studies
  • Working knowledge of current global regulatory requirements and guidelines governing clinical research

Qualifications:

  • 5+ years of clinical research experience
  • 2+ years of project management experience
  • Previous monitoring experience strongly preferred
  • Familiar with ICH/GCP guidelines
  • Experience managing complex trials in Rare Disease, Infectious Disease, or Oncology
  • Excellent teamwork, organizational, interpersonal, and problem solving skills
  • Proficient in Microsoft Office

If you are intereseted in exploring this opportunity, please email your CV to j.segal(at sign)realstaffing.com.

Sthree US is acting as an Employment Business in relation to this vacancy.