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CTM - Early Phase 2

Senior Clinical Project Manager (Clinical Trial Manager / Clinical Study Manager) - Cambridge, MA

Our client is looking for an experienced clinical project manager to join their growing office in Cambridge. They are currently developing products aimed at treating serious diseases involving the liver. This is an exciting opportunity for a passionate clinical project manager, who is looking to work with industry leaders.

Senior Clinical Project Manager (Clinical Trial Manager / Clinical Study Manager) - Cambridge, MA

Responsibilities:

  • Identify and assist in selection of external vendors required and the development of vendor specifications. Review and prepare vendor reports related to vendor proposals with recommendations
  • Participate in development and testing of clinical systems (e.g., data capture, IxRS)
  • Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team members, both internally and externally
  • Design clinical trial protocols with study team consistent with clinical development plan
  • Participate in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points
  • Communicate trial status, issues, and mitigations to relevant cross-functional stakeholders
  • Reviews and approves study related plans generated by Clinical CROs and vendors
  • Comply with regulatory, GCP, ICH, and SOP guidelines

Qualifications:

  • 5+ years of clinical research experience
  • 2+ years of clinical project management experience, preferably within an industry setting
  • Excellent organization and time management skills
  • Ability to track and report clinical trial timelines and resources
  • Strong initiative and positive attitude

If interested in exploring this opportunity, please send your CV to j.segal(at sign)realstaffing.com

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