Senior Clinical Project Manager

HemoShear Therapeutics

The Senior Clinical Project Manager is responsible for providing direct oversight, management and follow up for operational aspects of all assigned clinical studies. This role will lead and manage the project team to deliver the study in accordance with GCP, relevant SOP’s and regulatory requirements.

Key Responsibilities

  • Reports on key study performance information and metrics pertaining to time, cost and quality deliverables, including but not limited to study start-up metrics, enrollment, data collection timelines, etc.
  • Provide strategic/tactical planning, organization and direction of study project(s) including oversight of timelines, finances, monitoring, site and vendor management, clinical supplies, data collection, analyses and reporting
  • Lead and manage the project team to deliver the project in accordance with GCP, relevant SOP’s and regulatory requirements
  • Accountable for all project deliverables for each project assigned
  • Ensure all necessary training/coaching/mentoring is developed, delivered, and documented for assigned project staff

Experience and Qualifications

  • Bachelor’s degree in a life science or industry-related field is preferred
  • Minimum of ten (10) years’ experience in Clinical Operations, and three to five (3-5) years’ Study Lead and/or Project Management experience managing studies in a Biotech or CRO environment
  • Excellent working knowledge of ICH, GCP, and FDA guidelines and regulations

PREFERRED QUALIFICATIONS

  • High organizational, problem solving and analytical skills
  • Ability to work independently, make decisions and to progress projects
  • Excellent communicator, both in written and spoken language
  • Able to produce reports and project plans to a high standard
  • Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint

Sectors

  • Clinical Research
  • Therapeutics

Job Type

Full-time

Address

Charlottesville, Va.
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