Senior Clinical Trial Operations Manager

CPC

. Serve as the primary point of contact for industry-sponsored clinical trials and assigned projects .

Posted 10/22/2026full-timeRemote • Colorado • United StatesSenior💰 $100,000 - $140,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical trial management, including site identification, regulatory compliance, and project oversight. Proficient in mentoring teams and ensuring adherence to Good Clinical Practice guidelines and FDA regulations.

Highest-signal resume keywords

Clinical Research ManagementGood Clinical Practice KnowledgeProject Management SkillsTeam LeadershipRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementSite EvaluationBudget NegotiationRegulatory DocumentationIRB SubmissionsData ManagementSOP DevelopmentContract ManagementStatistical Analysis PlansMonitoring Reports

Soft Skills

Excellent CommunicationOrganizational SkillsAttention to DetailConflict ResolutionMentoring

Tools & Technologies

Microsoft OfficeStudy DatabasesProject Management Systems

Industry Keywords

Clinical TrialsFDA RegulationsICH RegulationsCRO ExperienceSponsor Management

About the role

Key responsibilities & impact

Serve as the primary point of contact for industry-sponsored clinical trials and assigned projects
Collaborate with department heads to ensure project service quality, resolve issues proactively, and improve project management systems and ARO efficiency
Mentor Clinical Operations Managers
Oversee clinical operations management activities delegated to Clinical Trial Managers
Manage site identification, evaluation, initiation, contracting, budget negotiation, monitoring, regulatory documentation, IRB submissions, site materials, monitoring reports, site compliance, enrollment reports, and site payments
Contribute to SOP review and development and process improvement
Define and monitor project scope, timelines, and deliverables from initiation through closeout
Identify project-specific training and ensure completion and documentation
Oversee trial-related activities and provide performance feedback
Participate in study database review, development, and testing
Track and manage investigational product or device disposition
Develop and manage site and vendor contracts and vendor services
Advise on and review project essential documents, including protocols, project management plans, case report forms, statistical analysis plans, ICF templates, study manuals, monitoring plans, and reports
Develop and manage multidisciplinary project teams and organize project team meetings
Identify project issues, propose resolutions, and track implementation through completion and efficacy checks
Ensure quality of project services and deliverables
Provide sponsor updates and reports
Plan and oversee investigator meetings
Support business development with budgets, proposals, change orders, benchmarking, and service agreements
Communicate project scope changes and project status to CPC management and sponsors
Provide TMF scope information and maintain compliance with regulations, CPC policies, SOPs, and work instructions
Supervise and evaluate direct-report staff, if applicable
Manage Endpoint and Specialty Services scope, timelines, and deliverables
Manage contracted deliverables for external committees, including scheduling, minutes, and meeting materials
Oversee SAE processes and safety plans
Track, process, and quality-check photos, acetate tracings, and other endpoint source documents
Oversee data entry and cleaning for study databases and maintain data management documentation
Manage endpoint materials supplied to study sites
Provide site feedback on tracing and quality issues
Manage and conduct CPC Core Lab activities as necessary

Requirements

What you’ll need

A Nursing or BA/BS in a scientific field (or equivalent knowledge/experience)
5 years of experience in a clinical research setting (required)
3 years of sponsor or CRO clinical research project/clinical operations management experience
Demonstrated ability to successfully execute all aspects of sponsor/CRO clinical trial management
Ability to mentor and oversee the activities of other COMs
Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials
Proficiency in Microsoft Office, particularly Outlook, Word and Excel
Excellent communication and organizational skills
Great attention to detail
Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting
Ability to organize, instruct and supervise staff while promoting group effort and achievement
Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively
Willingness to travel 20–25%
Successful completion of background and education verification check

Benefits

Comp & perks

Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
Matching 401(k) plan (dollar for dollar up to 4% of eligible compensation, fully vested immediately)
11 paid holidays
15–25 vacation days based on years of service
Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
Flexible and remote work schedules