Senior Manager, Clinical Operations

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🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $160k - $180k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Cookie Information

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2011

🤝 B2B

📋 Compliance

B2B • Compliance • Marketing

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📋 Description

• Leads the planning and execution of multicenter, potentially multinational phase 1-4 clinical studies, while contributing to broader clinical strategy and go-to-market readiness. • Responsible for the project timelines, budget development and resource planning, and partners cross-functionally to ensure clinical programs are aligned with development objectives, operational excellence, and downstream commercialization needs. • Ensures timely execution and completion of clinical trials while overseeing study teams and external partners to deliver high-quality clinical trials in compliance with applicable regionals and global regulations. • Serves as the primary operational lead for assigned studies, with accountability for timelines, budgets, resource planning, and delivery of key milestones. • Leads cross-functional Study Teams, including CRO/vendor staff, ensuring alignment of clinical execution with broader development strategy.

🎯 Requirements

• Accredited Bachelor's Degree • 5+ years of experience in pharmaceutical, biotech, or CRO industry • 3+ years of experience in clinical study management or monitoring (e.g., CRA, CTM, Study Manager) • Demonstrated experience managing global or multicenter clinical trials • History of managing sites in Pharma-sponsored clinical studies intended for use in NDA applications to FDA including monitoring visit scheduling, clinical site management, site training, site communication, query resolution, and generation of trip reports • Strong knowledge of the global drug development processes and regulatory requirements (ICH GCP, CFR) • Excellent written and verbal communication and presentation skills and ability to effectively work on remote cross-functional teams. • Ability to lead cross-functional teams and influence without direct authority • Strong project management skills, including planning, prioritization, and risk management • Ability to manage multiple priorities in a fast-paced, matrixed environment.

🏖️ Benefits

• flexible paid time off (PTO) • health benefits to include Medical, Dental and Vision • company match 401k