Senior Clinical Trial Operations Manager

Job not on LinkedIn

🔥 1 minute ago

⛰️ Colorado – Remote

⛰️ Colorado – Remote

💵 $100k - $140k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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CPC

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

📦 Logistics

💼 Consulting

Healthcare • Logistics • Consulting

CPC is a trusted tech partner that specializes in IT support and IT services, providing a wide range of solutions including sales and maintenance of new, used, and factory recertified computer hardware and software. Established in 1962, CPC leverages a deep bench of engineers and consultants to offer innovative and efficient IT solutions tailored to both businesses with or without internal IT departments. With a focus on value, innovation, reputation, and excellence, CPC supports various industries including remote work, healthcare, and manufacturing, ensuring businesses stay up, running, and protected. The company partners with leading tech brands such as Citrix, IGEL, LG, Nutanix, Arctic Wolf, NoMachine, Zebra Technologies, and DELL, and offers both new and refurbished equipment. CPC is committed to enhancing business operations through effective IT solutions and services.

📋 Description

• 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

• 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

• 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