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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.

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Clinical Project Manager

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