Senior Manager, Clinical Operations

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Directs the planning and implementation of multicenter, potentially multinational phase 1-4 clinical trials, while contributing to overarching clinical strategies and market readiness.

• Accountable for project timelines, budget formulation, and resource allocation, collaborating cross-functionally to ensure that clinical programs align with development goals, operational excellence, and commercialization requirements.

• Guarantees the timely execution and successful completion of clinical trials by overseeing study teams and external partners to ensure high-quality clinical trials in compliance with relevant regional and global regulations.

• Acts as the primary operational leader for designated studies, taking responsibility for timelines, budgets, resource planning, and achieving key milestones.

• Facilitates cross-functional Study Teams, including CRO/vendor personnel, ensuring that clinical execution aligns with the broader development strategy.

⛳️ Requirements

• Accredited Bachelor's Degree

• Over 5 years of experience in the pharmaceutical, biotech, or CRO sectors

• More than 3 years of experience in clinical study management or monitoring (e.g., CRA, CTM, Study Manager)

• Proven experience managing global or multicenter clinical trials

• Background in managing sites for Pharma-sponsored clinical studies intended for NDA applications to the FDA, including scheduling monitoring visits, clinical site management, training, communication, query resolution, and preparation of trip reports

• Strong understanding of global drug development processes and regulatory standards (ICH GCP, CFR)

• Exceptional written and verbal communication and presentation skills, with the ability to effectively collaborate within remote cross-functional teams.

• Capability to lead cross-functional teams and influence stakeholders without direct authority

• Robust project management skills, encompassing planning, prioritization, and risk management

• Proficient in managing multiple priorities in a dynamic, matrixed environment.

🏝️ Benefits

• Flexible paid time off (PTO)

• Health benefits including Medical, Dental, and Vision

• Company match 401k