Associate Project Coordinator

Associate Project Coordinator, Scientific Operations Location: Any US Location or Remote (EST working hours) Responsibilities: The Associate Project Coordinator is part of the project management team supporting the Project Manager. The role focuses on supporting execution activities using project management tools and established processes in the execution of Clinical Evaluation Reports, Summary of Safety and Clinical Performance Reports, Periodic Safety Update Report, Literature Search activities and Systematic Literature Reviews. Responsibilities:

• Provides project coordination support to Medical Operations staff using established tools, systems, and practices
• Coordinates the receipt of documents that are required inputs to Medical Operations deliverables, including downloading documents from the Quality System
• Sets up and drives meetings for project execution per project plan, as well as meetings in support of the project management process
• Drives communication with the project team, including cross-functional partners (such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, Clinical Affairs and Regulatory Affairs), sharing deliverables for review and approval.
• Ensures project timelines are met and established tools and practices are consistently utilized
• Maintains and monitors metrics relevant to the team activities providing visibility of issues to enable corrective and preventive action to be taken, as needed.
• Knowledge and access to applicable Quality Systems to support the teams in routing of documents for approval as well as change orders for document revisions, as required

Education & Experience Requirements:

• Bachelors degree in a technical discipline is required
• Minimum of 2 years of related job experience is required
• Demonstrated knowledge and experience in project management principles and methodologies is required
• Strong written and oral communication skills is required
• Proficient using Microsoft Project Applications (specifically Word, Excel, Project, Outlook, and PowerPoint), and Adobe Acrobat
• Experience within the medical device industry and knowledge of clinical evaluation report
• regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation is preferred.
• Experience with Project Manager Software – Wrike is preferred.

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