Project Manager, Internal Evaluations (Hybrid - Acton, MA)

Insulet Corporation•Acton, MA

20h•Hybrid

About The Position

The Project Manager is responsible for designing, managing, executing, and analyzing data generated from Insulet’s Internal Evaluations throughout the R&D development program and sustaining activities. The Internal Evaluation Manager may also be called upon to support decentralized and external clinical studies, as required.

Requirements

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

Nice To Haves

Biomedical engineering and/or diabetes therapeutic experience highly desired.

Responsibilities

Partner with Program Managers to ensure programs are managed efficiently and effectively by participating and driving all phase of development starting with concept through design transfer
Manage the maintenance of a shared site that organizes and updates central project documents and manage access to the site for users.
Aid in the preparation of project status presentations to Management regularly.
Prepare project summary reports, develop and track project plans.
Work cross functionally with members of the R&D team to determine internal evaluation project needs.
Identify internal evaluation objectives to ensure they align with the business needs and provide recommendations to the cross functional design team.
Determine the type of testing appropriate given the project’s stage of development or product needs.
Participate and provide input during internal evaluation meetings to help design the evaluation based on needs of the business.
Ensure internal evaluation timelines are being managed and communicated to key stakeholders.
Prepare and critically review project related study documents including but not limited to: protocols, informed consent, and IRB submissions.
Work with cross functional team to define project needs and develop evaluation guides to convey requirements successfully.
Oversee aspects of the internal evaluation studies including Identifying and recruiting potential participants.
Informed consent discussions.
Training of all participants.
Preparation of device kits.
Process the compensation of internal evaluation participants.
Troubleshoot execution issues during the internal evaluation.
Manage evaluation documentation and databases.
Support the cross functional team to report on metrics.
Support other clinical study activities within the department as needed.
Willing to come into the Acton office as needed to support the evaluation efforts.
Perform other duties as required.