Clinical Project Manager

Clinical Project Manager - Medical Device Clinical Trials

Location: Acton, MA (Open to Remote - Eastern Standard Time)

Pay Rate: Up to $74/hour

We are seeking an experienced Clinical Project Manager to lead medical device clinical investigations across the full study lifecycle-from study design and start-up through closeout. This role drives operational excellence, regulatory compliance, and inspection readiness while supporting premarket and post-market clinical evidence strategies.

Key Responsibilities:

• Lead study planning, feasibility assessments, site selection, and investigator qualification activities.
• Develop and review key clinical trial documents including protocols, informed consent forms, monitoring plans, and EDC inputs.
• Manage end-to-end clinical trial operations, overseeing CROs, vendors, and multi-site study execution.
• Track enrollment, timelines, budgets, milestones, and risk mitigation plans to ensure on-time, high-quality deliverables.
• Partner with Medical Affairs and Regulatory Affairs to support U.S. and global regulatory submissions.
• Ensure compliance with GCP, FDA, IRB/EC requirements, and internal SOPs; maintain TMF/eTMF audit readiness.
• Monitor protocol deviations, safety reporting, CAPA inputs, and quality documentation processes.
• Support clinical data review, study reports, regulatory documentation, and Design History File (DHF) contributions.

Qualifications:

• Bachelor's degree in Life Sciences or related field.
• 5+ years of medical device or pharmaceutical clinical research experience; 2+ years of direct clinical project management experience preferred.
• Experience managing CROs, vendors, and multi-site clinical trials.
• Knowledge of FDA regulations, IDE processes, IRB/EC submissions, and GCP standards.
• Strong analytical, risk management, and cross-functional leadership skills.

Travel approximately 10% (domestic and international).

Employee Benefits

Medical, dental, vision, and pet insurance | 401(k) Retirement Savings Plans | Employee Assistance Program (EAP) | Commuter/Parking Accounts | People Perks | Health Savings Account (HSA) | AD & D Insurance

If you are a results-driven clinical research professional ready to lead high-impact medical device studies, click Apply Now.

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