Senior Manager, Clinical Operations

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🕒 June 4

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Cookie Information

51 - 200 employees

Founded 2011

🤝 B2B

📋 Compliance

B2B • Compliance • Marketing

Cookie Information is a leading consent management platform that simplifies the process of collecting user consent for cookies and tracking on websites and mobile applications. It is designed for marketers to ensure compliance with privacy regulations like GDPR, while enhancing marketing performance. The platform provides customizable cookie banners that integrate with various systems, enabling businesses to manage cookie consent effectively and maintain regulatory compliance without sacrificing their marketing capabilities.

📋 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

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