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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