Senior Clinical Trial Operations Manager

CPC Clinical Research • Aurora, CO

1d • $100,000 - $140,000 • Remote

About The Position

The Senior Clinical Trial Operations Manager serves as the primary point of contact for industry-sponsored clinical trials and other assigned projects. The role works closely with the Head of Research and Community Health Operations and the Head of Endpoint and Specialty Services to ensure high-quality project services, resolve issues proactively, and improve project management systems and organizational efficiency. The manager mentors Clinical Operations Managers, oversees clinical trial management activities, and may directly manage site operations for single-site or smaller multicenter studies when those activities are not delegated to a Clinical Trial Manager.

The position is responsible for defining and monitoring project scope, timelines, and deliverables from initiation through closeout; managing project teams, vendors, contracts, budgets, and sponsor communications; and ensuring quality and compliance with applicable regulations, policies, and procedures. It also provides expert input on study documents, supports business development proposals and budgets, oversees investigator meetings, and tracks project issues through resolution.

For Endpoint and Specialty Services, the role defines and monitors scope, timelines, and deliverables; coordinates contracted external committee services; oversees safety processes and study database activities; and manages receipt, processing, and quality of endpoint materials and documents. Remote candidates are welcome. The position requires 20–25% travel.

Requirements

• Nursing degree or BA/BS in a scientific field, or equivalent knowledge and experience.
• At least 5 years of experience in a clinical research setting.
• At least 3 years of sponsor or CRO clinical research project or clinical operations management experience.
• Demonstrated ability to execute all aspects of sponsor/CRO clinical trial management and to mentor and oversee other Clinical Operations Managers.
• Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for clinical drug trials.
• Proficiency in Microsoft Office, particularly Outlook, Word, and Excel.
• Excellent communication and organizational skills.
• Strong attention to detail.
• Exemplary ability to lead and manage multidisciplinary teams in a clinical research setting.
• Ability to organize, instruct, and supervise staff while promoting group effort and achievement.
• Ability to adapt quickly, manage conflicts, and resolve problems effectively.
• Willingness to travel 20–25%.
• Successful applicants must pass background and education verification.

Responsibilities

• Coordinate with department heads to ensure quality project services, resolve issues proactively, and improve project management practices and organizational efficiency.
• Mentor Clinical Operations Managers and provide guidance on activities needed to maintain the quality of project services and deliverables.
• Oversee clinical operations management delegated to a Clinical Trial Manager and directly manage applicable activities for single-site or smaller multicenter studies.
• Manage site identification, evaluation, initiation, contracting and budget negotiation, and monitoring as required by contract.
• Identify regulatory documents required for investigational product release and oversee their collection.
• Prepare central IRB submissions, oversee site IRB approvals, and ensure collection of new or expiring investigator regulatory documents after site activation.
• Oversee development of essential project documents for site oversight and site materials.
• Review and finalize monitoring visit reports and follow-up letters with Clinical Research Associates.
• Work with CRAs to manage sites and identify and resolve site compliance issues.
• Prepare enrollment reports and review site issues with the project team.
• Manage and approve site payments as applicable.
• Contribute to process improvement, including reviewing or developing SOPs and methods to improve the quality of sponsor deliverables.
• Define and monitor project scope, timelines, and deliverables from initiation to closeout in collaboration with department leadership.
• Identify project-specific training and notify the appropriate designee to ensure training completion and filing.
• Oversee trial-related activities and provide performance feedback to supervisors for project team members.
• Participate in review, development, and testing of study databases.
• Track and manage investigational product or device disposition as required by the project.
• Develop and manage site and vendor contracts, including contracts for IP supply, interactive voice/web response systems, electronic data capture systems, core labs, and other clinical services.
• Identify vendors and manage vendor services.
• Provide expert advice on the design, writing, and review of project documents, including protocols, management plans, case report forms, statistical analysis plans, ICF templates, procedure manuals, source documents, newsletters, reports, resource tools, monitoring plans, and report templates.
• Develop and manage multidisciplinary project teams; organize and plan team meetings and produce meeting minutes.
• Identify project issues, propose resolutions to relevant teams, department heads, executives, or sponsors, and track resolutions through implementation and efficacy checks.
• Ensure the overall quality of project services and deliverables.
• Provide sponsor updates and reports as specified in the contract.
• Plan and oversee investigator meetings as contracted.
• Work with Business Development on budgets, proposals, and change orders, including budget benchmarking and sponsor proposals and service agreements.
• Ensure CPC and sponsors agree on project scope changes with financial or resource impacts, provide timely assignment updates to the Head of Research and Community Health Operations, and advise management on project status.
• Provide the Head of Trial Master File with service scope information to support establishment and maintenance of electronic and paper TMFs and project document files.
• Comply with applicable local, federal, and international regulations, guidelines, CPC policies, SOPs, and work instructions; identify and document necessary deviations.
• Supervise and evaluate staff reporting to the position, if applicable.
• Define and monitor Endpoint and Specialty Services scope, timelines, and deliverables with the assigned Clinical Operations Manager and Head of Endpoint and Specialty Services.
• Provide project progress updates to the Heads of Research and Community Health Operations and Endpoint and Specialty Services, and advise management on overall project status.
• Manage contracted deliverables for external committees, including meeting scheduling, minutes, and distribution of meeting materials.
• Oversee the SAE process and ensure safety plans are executed.
• Track receipt, entry, upload, and processing of photos, acetate tracings, and other site-submitted source documents.
• Contact site staff or CRAs about incomplete, inaccurate, or missing endpoint and core lab documents.
• Oversee timely and accurate data entry and cleaning for study databases and maintain required data management documentation.
• Manage acquisition and supply of Endpoint and Specialty Services-specific materials for study sites.
• Provide feedback to sites on tracing and quality issues as required.
• Manage and conduct CPC Core Lab activities as needed.

Benefits

• Comprehensive benefits package, including medical, dental, vision, life, short-term disability, and long-term disability coverage.
• Dollar-for-dollar 401(k) match up to 4% of eligible compensation, fully vested immediately.
• 11 paid holidays.
• 15–25 vacation days based on years of service.
• Paid sick time accrued at 2.67 hours bi-weekly, up to a maximum of 80 hours.
• Flexible and remote work schedules.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior