Clinical Project Manager

Advantage Technical; Massachusetts; Remote; USD 80,000 - 100,000; Full time

Job summary

A clinical research organization is seeking a detail-oriented Clinical Project Manager to oversee Investigator Initiated Studies (IIS). This role involves cross-functional collaboration managing device logistics, data coordination, and project documentation. With a requirement for a Bachelor's degree and several years of experience in clinical research, applicants must demonstrate strong project management skills. The position offers flexible work arrangements including remote options.

Qualifications

• 3–7 years of experience in clinical research related to medical devices or pharmaceuticals.
• Minimum 2 years of project management experience.
• Experience in biomedical engineering and/or diabetes therapeutics preferred.

Responsibilities

• Collaborate with Medical Affairs to manage study device logistics.
• Coordinate with Manufacturing, R&D, and Engineering teams.
• Develop and maintain project plans and summary reports.
• Monitor and communicate project timelines to stakeholders.

Skills

Project Management

Clinical Research Knowledge

Analytical Skills

Communication Skills

Organizational Skills

Education

Bachelor's degree in Biomedical Engineering or Life Sciences

Tools

Microsoft Office Suite

Project Tracking Tools

Job description

Clinical Project Manager – Investigator Initiated Studies

Location: Preference for candidates local MA; open to remote

Schedule: Minimum 20 hours/week, up to 40 hours/week based on availability

Remote Eligible: Yes, 100% remote or hybrid arrangements available

Position Summary

We are seeking a detail-oriented and proactive Clinical Project Manager to support Investigator Initiated Studies (IIS) within our clinical research operations. This role involves cross-functional collaboration to manage study device logistics, data coordination, and project documentation. The ideal candidate will bring strong project management experience, clinical research knowledge, and the ability to navigate a dynamic, fast-paced environment.

Key Responsibilities

• Collaborate with the Medical Affairs team to manage requests for study devices and device data
• Coordinate with Manufacturing, R&D, and Engineering teams to procure devices for IIS
• Work with the Cloud team to establish remote monitoring capabilities and facilitate data exports
• Ensure execution of necessary agreements and contracts
• Prioritize incoming requests to optimize resource allocation
• Assist in preparing project status updates and presentations for senior management
• Develop and maintain project plans and summary reports
• Manage a centralized shared site for project documentation and user access
• Monitor and communicate project timelines to stakeholders
• Review study protocols to determine device quantity requirements
• Estimate device and resource costs for each study
• Support additional clinical study activities as needed
• Willingness to work on-site in MA as required
• Perform other duties as assigned

Qualifications

• Bachelor’s degree required; preferred fields include Biomedical Engineering or Life Sciences
• 3–7 years of experience in clinical research related to medical devices or pharmaceuticals
• Minimum 2 years of project management experience
• Experience in biomedical engineering and/or diabetes therapeutics strongly preferred
• Strong analytical skills and attention to detail
• Familiarity with regulatory guidelines and agency requirements

Skills and Competencies

• Excellent written and verbal communication skills
• Strong organizational and project management capabilities
• Ability to manage multiple priorities and timelines
• Comfortable communicating across all levels of the organization
• Proficiency in Microsoft Office Suite and project tracking tools
• Skilled in internet research and digital collaboration platforms
• Adaptable and effective in a fast-paced environment
• Collaborative team player

Additional Information

• Estimated travel (domestic and international): approximately 10% annually
• This position supports flexible work arrangements, including fully remote or hybrid options