Job Description

Job Title: Clinical Project Manager – Investigator Initiated Studies

Responsibilities:

• Collaborate with Medical Affairs to manage study device and data requests.
• Work cross-functionally with Manufacturing, R&D, and Engineering to procure study devices.
• Partner with technical teams to set up remote monitoring and data exports.
• Oversee execution of agreements and contracts.
• Prioritize requests to optimize resources and timelines.
• Prepare project plans, status updates, and summary reports for management.
• Maintain and update a shared site for central project documents.
• Review protocols to determine device needs and study requirements.
• Estimate device and resource costs per study.
• Support other clinical study activities as needed.
• Perform additional duties as assigned.

Education & Experience:

• Bachelor’s degree in Biomedical Engineering, Life Sciences, or related field.
• 3–7 years in medical device or drug-related clinical research.
• Minimum 2 years of project management experience.
• Biomedical engineering and/or diabetes therapeutic experience preferred.
• Strong analytical, organizational, and interpersonal skills.
• Knowledge of regulatory guidelines.

Skills & Competencies:

• Excellent verbal and written communication.
• Proficient in project management and multi-tasking.
• Skilled in MS Office, databases, and timeline software.
• Ability to communicate across all organizational levels.
• Flexible, detail-oriented, and a strong team player.

Other Requirements:

• Willingness to work on-site in Acton, MA as needed.
• Approximately 10% domestic/international travel.

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