Senior Manager Clinical Operations
$160,000–$180,000 year
Remote · United States
Job Summary
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. The role requires coordinating CRO/vendor oversight, ensuring regulatory compliance (ICH GCP, CFR), risk management, data integrity, safety reporting, and effective communication with senior stakeholders to drive program success.
Required Qualifications
- 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
- Preferred Education, Experience, and Skills includes master’s degree, 7+ years, regulatory experience, CRO oversight, therapeutic area CNS, CTMS/EDC proficiency
- Therapeutic area experience (e.g., CNS) and large molecule development
- Proficiency with clinical systems (e.g., EDC, CTMS, eTMF) and project management
- Willingness to travel up to 30% domestically; international travel may be required
- Salary Pay Range: $160,000 - $180,000 and eligibility for a 15% bonus target
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