Senior Clinical Project Manager

Seeking a highly organized and communicative Senior Clinical Project Manager to lead complex clinical studies, manage vendor relationships, and ensure regulatory compliance. The role involves setting up new clinical sites, overseeing project budgets, and delivering high-quality study reports.

Job Title: Senior Clinical Project Manager
Location: Remote
Type: Direct Hire
Hours: 40.0 hours per week

Overview
Seeking a highly organized and communicative Senior Clinical Project Manager to lead complex clinical studies, manage vendor relationships, and ensure regulatory compliance. The role involves setting up new clinical sites, overseeing project budgets, and delivering high-quality study reports. Ideal candidates will have extensive experience in regulated clinical research and proven leadership capabilities.

Responsibilities

• Lead and manage complex studies from start-up to close-out
• Drive budget management while leading complex projects
• Perform vendor management and serve as the dotted line manager for CRAs and a junior PM
• Ensure compliance with regulated project requirements, including pre-market IDE experience
• Set up and add several new sites over the next few years
• Complete medical writing study reports and perform quality audits

Requirements

• Bachelor’s degree required; scientific background preferred
• 10+ years of experience in clinical research
• Experience with medical device research, especially regulated projects
• Strong understanding of clinical research processes and vendor management
• Experience managing budgets and performing quality audits
• Experience setting up clinical sites is important
• Ability to manage complex projects and lead cross-functional teams

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: # 568-Clinical