Senior Clinical Operations Manager

The role is for an experienced Senior Clinical Operations Manager responsible for overseeing industry-sponsored clinical trials and related projects, ensuring quality, compliance, and efficiency.

Location: Remote

Salary: $95,045 - $118,806 annually

Responsibilities

• Serve as the primary point of contact for industry sponsored clinical trials and assigned projects.
• Ensure overall quality of project services, proactive issue resolution, and development of systems to standardize and improve project management practices.
• Mentor other Clinical Operations Managers and oversee clinical operations management activities.
• Manage site identification, evaluation, initiation, contracting/budget negotiation, and site monitoring processes.
• Oversee regulatory documents, IRB submissions, and site regulatory compliance.
• Review and finalize monitoring visit reports and follow-up letters.
• Work with CRAs on site management and compliance issues.
• Manage project scope, timelines, and deliverables from initiation to close-out.
• Identify project-specific training needs and oversee team performance.
• Participate in database review, development, and testing.
• Manage investigational product or device tracking and disposition.
• Develop and manage site and vendor contracts, including supply and services.
• Provide expert advice on project documentation and management plans.
• Develop and manage multidisciplinary project teams.
• Identify and resolve project issues, track resolutions, and ensure quality.
• Provide updates and reports to sponsors.
• Plan and oversee investigator meetings.
• Work with business development on budgets, proposals, and change orders.
• Ensure compliance with regulations, policies, and SOPs.
• Supervise and evaluate staff performance.
• Define and monitor scope, timelines, and deliverables for Endpoint and Specialty Services.
• Manage external committee deliverables, safety processes, and data management for Endpoint and Specialty Services.
• Qualifications include a Nursing or BA/BS in a scientific field, 5 years of clinical research experience, 3 years of project management experience, knowledge of GCP, FDA, ICH regulations, and proficiency in Microsoft Office.
• Willingness to travel 20-25%.
• Targeted compensation: $95,045 - $118,806 annually.
• Application deadline: September 1, 2026.
• Note: Background and education verification required.

Requirements

• Nursing or BA/BS in a scientific field (or equivalent).
• 5 years of experience in a clinical research setting.
• 3 years of sponsor or CRO clinical research project/clinical operations management experience.
• Demonstrated ability to manage all aspects of clinical trial management and mentor staff.
• Thorough knowledge of GCP, FDA, and ICH regulations.
• Proficiency in Microsoft Office.
• Excellent communication and organizational skills.
• Great attention to detail.
• Leadership skills in managing multidisciplinary teams.
• Ability to adapt quickly, manage conflicts, and resolve problems.
• Willingness to travel 20-25%.

Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD).
• Matching 401(k) plan (dollar for dollar up to 4%).
• 11 paid holidays.
• 15-25 vacation days based on years of service.
• Paid sick time (up to 80 hours).
• In-suite exercise and relaxation room.
• Monthly team-building and charitable events.
• Flexible and remote work schedules.

Additional Information

• Applicants must pass a background and education verification check.
• CPC is an equal opportunity employer committed to diversity and inclusion.
• Disability accommodations available upon request.