Senior Clinical Trial Operations Manager

CPC Clinical Research • Aurora, CO

2d • 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 project quality, resolve issues proactively, and improve project management systems and organizational efficiency. The manager mentors Clinical Operations Managers, oversees clinical operations delegated to Clinical Trial Managers, and manages trial operations directly when those activities are not delegated.

Responsibilities span study and site management, regulatory and IRB documentation, project scope and timelines, vendor and contract management, study materials and essential documents, data and investigational product oversight, team leadership, sponsor communications, quality assurance, and process improvement. The role also supports business development activities, including budgets and proposals, and provides project status updates to management.

For Endpoint and Specialty Services projects, the manager defines and monitors scope, timelines, and deliverables; coordinates external committee deliverables; oversees safety processes and source-document handling; monitors data entry and cleaning; manages study-site materials; and conducts core lab activities as needed. The position requires adherence to applicable regulations, guidelines, policies, procedures, and work instructions. Remote candidates are welcome to apply, and travel of 20–25% is expected.

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 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.
• Great 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 teamwork and achievement.
• Ability to adapt quickly to new situations, manage conflicts, and resolve problems effectively.
• Willingness to travel 20–25%.
• Successful applicants must pass background and education verification checks.

Responsibilities

• Serve as the primary point of contact for industry-sponsored clinical trials and assigned projects.
• Work with the Heads of Research and Community Health Operations and Endpoint and Specialty Services to ensure service quality, resolve issues proactively, and improve project management practices and organizational efficiency.
• Mentor Clinical Operations Managers and provide guidance on maintaining the quality of project services and deliverables.
• Oversee clinical operations management activities delegated to a Clinical Trial Manager.
• For studies without a delegated CTM, manage site identification, evaluation, initiation, contracting and budget negotiation, and monitoring as required by contract.
• Identify regulatory documents needed 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 activation.
• Oversee development of project-specific essential 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 when applicable.
• Contribute to process improvement, including reviewing or developing SOPs and improving the quality of sponsor deliverables.
• Define and monitor project scope, timelines, and deliverables from initiation through closeout in collaboration with the Head of Research and Community Health Operations.
• Identify project-specific training and notify the appropriate designee to ensure completion and filing of training documentation.
• Oversee trial-related activities and provide performance feedback to supervisors for project team members.
• Participate in the 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 in designing, writing, or reviewing project documents, including protocols, project 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 team members.
• Organize and plan project team meetings and produce meeting minutes.
• Identify project issues, propose resolutions to project teams, department heads, CPC executives, or sponsors, and track resolution implementation and efficacy checks.
• Ensure the overall quality of project services and deliverables.
• Provide sponsor updates and reports as specified by contract.
• Plan and oversee investigator meetings as contracted.
• Work with Business Development on budgets, proposals, and change orders; assist with budget benchmarking and sponsor proposals and service agreements.
• Ensure CPC and the sponsor understand and agree on project-scope changes with financial or resource impacts.
• Provide timely progress feedback to the Head of Research and Community Health Operations and routinely advise management on project status.
• Provide the Head of Trial Master File with the scope of services needed to establish and maintain electronic and paper TMFs and project document files.
• Follow applicable local, federal, and international regulations, guidelines, CPC policies, SOPs, and work instructions; identify and document justified deviations appropriately.
• 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 progress updates to the Heads of Research and Community Health Operations and Endpoint and Specialty Services, and routinely advise management on 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 source documents submitted by sites.
• Contact site staff or CRAs about incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required.
• 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 sites with feedback on tracing and quality issues as required.
• Manage and conduct CPC Core Lab activities as needed.
• Perform additional activities as required.

Benefits

• Comprehensive benefits package, including medical, dental, vision, life, short-term disability, and long-term disability coverage.
• 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 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