Clinical Operations Manager

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

📋 Description

• Manage clinical operations activities effectively.

• Establish and oversee project scope, timelines, and deliverables from initiation to completion.

• Determine project-specific training needs for team members and inform designated personnel to ensure training documentation is completed and filed.

• Supervise activities related to trials.

• Monitor and authorize vendor payments.

• Offer expert guidance in the design, drafting, and review of all essential project documents, including protocols, project management plans, case report forms, statistical analysis plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, monitoring plans, and report templates.

• Develop and supervise multidisciplinary project team members.

• Organize, plan, and document minutes for project team meetings.

• Ensure the overall quality of project services and deliverables.

• Provide necessary updates and reports to the sponsor as specified in the contract.

• Plan and oversee the execution of investigator meetings as per contract agreements.

• Collaborate with the Business Development team on budgets, proposals, and change orders.

• Ensure that both CPC and the sponsor are informed of and agree on any changes in project scope that may affect financials or resources.

• Provide the Head of Trial Master File with the scope of services needed to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper.

• Comply with local, federal, and international regulations, guidelines, as well as CPC Policies, Standard Operating Procedures (SOPs), and Work Instructions (WIs).

• Exercise appropriate discretion to proactively identify the necessity to deviate from policies, procedures, or plans, ensuring all deviations are documented properly.

• Define and monitor the scope, timelines, and deliverables for Endpoint and Specialty Services from project initiation to closeout, with the support of the assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.

• Manage contracted deliverables for external committees (e.g., data safety monitoring boards, clinical endpoint committees), which includes meeting scheduling, generating meeting minutes, and distributing meeting materials.

• Oversee the SAE process and ensure the implementation of safety plans.

• Track the receipt, entry, upload, and processing of photos, acetate tracings, and other source documents submitted from sites accurately.

• Communicate with relevant individuals (e.g., study site staff or Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.

• Ensure timely and accurate data entry and cleaning for all study databases, maintaining and filing data management documentation as necessary.

• Provide feedback to study sites regarding tracing and quality issues as required by the project.

• Manage and conduct Endpoint and Specialty Services CPC Core Lab activities.

• Offer operational support for biostatistics and programming deliverables.

⛳️ Requirements

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

• A minimum of 4 years of experience in a clinical research environment, with at least 2 years in project/operations management within clinical research preferred.

• Proven ability to manage all aspects of a clinical trial with minimal supervision.

• 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.

• Strong communication and organizational skills.

• Exceptional attention to detail.

• Proven ability to lead and manage multidisciplinary teams in a clinical research context.

• Capable of organizing, instructing, and supervising project staff while fostering group collaboration and success.

• Ability to quickly adapt to new situations, manage conflicts, and resolve issues effectively.

• Willingness to travel 20-25%.

🏝️ Benefits

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

• Matching 401(k) plan (dollar for dollar up to 4% of your 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).

• Monthly fun events (such as team building activities, games, charitable events, potlucks, picnics).

• Flexible and remote work schedules.