Clinical Project Manager Job at Gardner Resources Consulting, LLC, Acton, MA

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  • Gardner Resources Consulting, LLC
  • Acton, MA

Job Description

Job Description

Clinical Project Manager

Responsibilities:

  • Liase with the Medical Affairs team to manage request for study devices and device data for Investigator Initiated Studies
  • Liase cross-functionally with the Manufacturing, R&D and Engineering teams to procure study devices for Investigator Initiated Studies
  • Liase with the Cloud team to set up remote monitoring capabilities and export device data to relevant stakeholders for Investigator Initiated Studies.
  • Ensure appropriate agreements and contracts are executed.
  • Determine the priority of requests to ensure efficient resource management.
  • Aid in the preparation of project status presentations to Management regularly.
  • Prepare project summary reports, develop and track project plans.
  • Manage the maintenance of a shared site that organizes and updates central project documents and manage access to the site for users.
  • Ensure timelines are being managed and communicated to key stakeholders.
  • Review study protocols and other documentation to determine the appropriate quantity of devices needed per study.
  • Estimate the total cost of devices and resources required for each study
  • Support other clinical study activities within the department as needed.
  • Willing to come into the Acton office as needed.
  • Perform other duties as required.

Education and Experience:

  • Bachelor’s Degree (preferably in Biomedical Engineering or Life Science field)
  • 3-7 years of medical device or drug related clinical experience or an equivalent combination of education and experience.
  • At least 2 years project management experience is required
  • Biomedical engineering
  • Must have analytical skills, be detail oriented and have good interpersonal skills.
  • Knowledge of agency guidelines and requirements.

Skills/Competencies:

  • Excellent written and effective verbal communication skills.
  • Proficient project management skills.
  • Ability to prioritize multiple timelines and tasks.
  • Ability to communicate at all levels of an organization.
  • PC skill, word processing, spreadsheet, database, timeline software.
  • Internet search and utilization.
  • Flexible and able to work in a fast paced environment.
  • Team player.

Physical Requirements

  • Estimated travel (domestic and international) is approximately 10% per year.

Job Tags

Work at office, Flexible hours,

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