Senior Clinical Trial Operations Manager

This is a fully remote position, open to applicants in Colorado.

📋 Description

• Act as the main point of contact for industry-sponsored clinical trials and designated projects.

• Partner with department leaders to guarantee the quality of project services, proactively address issues, and enhance project management systems and ARO efficiency.

• Guide Clinical Operations Managers through mentorship.

• Supervise clinical operations management tasks assigned to Clinical Trial Managers.

• Handle site identification, evaluation, initiation, contracting, budget negotiations, monitoring, regulatory documentation, IRB submissions, site materials, monitoring reports, site compliance, enrollment reports, and site payments.

• Contribute to the review and development of SOPs and process improvements.

• Define and track project scope, timelines, and deliverables from initiation to closeout.

• Identify project-specific training needs and ensure completion and documentation.

• Oversee trial-related activities and provide performance evaluations.

• Engage in the review, development, and testing of study databases.

• Monitor and manage the disposition of investigational products or devices.

• Develop and manage contracts and services with sites and vendors.

• Advise on and review essential project documents, such as protocols, project management plans, case report forms, statistical analysis plans, ICF templates, study manuals, monitoring plans, and reports.

• Build and manage multidisciplinary project teams and organize project team meetings.

• Identify project challenges, suggest solutions, and oversee implementation through to completion and efficacy assessments.

• Ensure the quality of project services and deliverables.

• Provide updates and reports to sponsors.

• Plan and manage investigator meetings.

• Assist in business development activities, including budgets, proposals, change orders, benchmarking, and service agreements.

• Communicate changes in project scope and status to CPC management and sponsors.

• Provide TMF scope information and ensure compliance with regulations, CPC policies, SOPs, and work instructions.

• Supervise and evaluate direct-report staff, if applicable.

• Manage the scope, timelines, and deliverables for Endpoint and Specialty Services.

• Oversee contracted deliverables for external committees, including scheduling, minutes, and meeting materials.

• Supervise SAE processes and safety plans.

• Track, process, and perform quality checks on photos, acetate tracings, and other endpoint source documents.

• Oversee data entry and cleaning for study databases, maintaining data management documentation.

• Manage endpoint materials provided to study sites.

• Offer site feedback regarding tracing and quality issues.

• Manage and conduct CPC Core Lab activities as needed.

⛳️ Requirements

• A Nursing degree or a BA/BS in a scientific discipline (or equivalent knowledge/experience).

• 5 years of experience in a clinical research environment (required).

• 3 years of experience in clinical research project or clinical operations management for sponsors or CROs.

• Proven ability to successfully manage all aspects of sponsor/CRO clinical trial management.

• Capability to mentor and oversee the activities of other Clinical Operations Managers.

• Comprehensive understanding of Good Clinical Practice guidelines and relevant FDA and ICH regulations for conducting clinical drug trials.

• Proficient in Microsoft Office, especially Outlook, Word, and Excel.

• Exceptional communication and organizational skills.

• Strong attention to detail.

• Outstanding ability to lead and manage multidisciplinary teams in a clinical research setting.

• Ability to organize, instruct, and supervise staff while fostering group effort and achievement.

• Adaptability to new situations, effectively managing conflicts and resolving problems.

• Willingness to travel 20–25% of the time.

• Successful completion of background and education verification checks.

🏝️ Benefits

• Comprehensive benefits package including medical, dental, vision, life, STD, LTD, etc.

• 401(k) plan with matching contributions (dollar for dollar up to 4% of eligible compensation, fully vested immediately).

• 11 paid holidays.

• 15–25 vacation days depending 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.