Senior Clinical Operations Manager

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

📋 Description

• Collaborate closely with the Head of Research and Community Health Operations and the Head of Endpoint and Specialty Services to ensure the overall quality of project services, proactive issue resolution, and the development of systems aimed at standardizing and enhancing project management practices as well as the efficiency of ARO.

• Act as a mentor for other Clinical Operations Managers, offering guidance on the necessary efforts and activities to uphold the overall quality of project services and deliverables.

• Supervise clinical operations management tasks when delegated to a Clinical Trial Manager (CTM).

• For single-site or smaller multi-center studies where these activities are not assigned to a CTM: Manage site identification, evaluation, initiation, contracting/budget negotiation, and site monitoring processes as dictated by contract.

• Identify the regulatory documents required for investigational product (IP) release and oversee the collection of these documents.

• Prepare central IRB submissions; supervise site IRB approvals and ensure the collection of all new or expiring Investigator regulatory documents post-site activation.

• Oversee the creation of project-specific essential documents for site oversight and the development of site materials.

• Review and finalize monitoring visit reports and follow-up letters in collaboration with Clinical Research Associates (CRAs).

• Work with CRAs on overall site management, including the identification and resolution of site-related compliance issues.

• Prepare study enrollment reports and discuss site issues with the project team.

• Manage and approve site payments as necessary.

• Contribute to process enhancements, including but not limited to reviewing and/or developing SOPs, as well as creating and/or implementing methods to improve the quality of sponsor deliverables.

• Define and monitor project scope, timelines, and deliverables from project initiation to close-out in collaboration with the Head of Research and Community Health Operations.

• Identify project-specific training for team members and inform the appropriate designee to guarantee the completion and filing of training documentation.

• Supervise trial-related activities and provide performance feedback to supervisors for all project team members.

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

• Provide tracking and disposition of investigational products or devices as required by the project.

• Develop and manage contracts with sites and vendors, including investigational product (IP) supply, interactive voice/web response systems, electronic data capture systems, core labs, and other relevant clinical services.

• Identify vendors and manage their services.

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

• Develop and manage multidisciplinary project team members.

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

• Proactively identify project issues, propose solutions to the project team, relevant department heads, CPC executives, and/or the sponsor, and track the implementation and efficacy of resolutions through to completion.

• Ensure the overall quality of project services and deliverables.

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

• Plan and oversee the execution of investigator meetings as contracted.

• Collaborate with the business development team on budgets, proposals, and change orders.

• Assist Business Development with benchmarking for budgets and the creation of sponsor proposals and service agreements.

• Ensure that both CPC and the sponsor are informed and in agreement on any changes in project scope that may have a financial or resource impact.

• Provide timely feedback to the Head of Research and Community Health Operations regarding the progress of project assignments.

• Regularly update management on the overall project status.

• Provide the Head of Trial Master File with the scope of services required to enable the establishment and maintenance of Trial Master Files (TMFs) and project document files, both electronic and paper.

• Adhere to local, federal, and international regulations, guidelines, CPC Policies, Standard Operating Procedures (SOPs), and Work Instructions (WIs).

• Use appropriate discretion to proactively identify when deviations from policies, procedures, or plans are necessary and ensure such deviations are properly documented.

• Supervise and assess the performance of all staff reporting to this position, if applicable.

• Undertake additional activities as required.

⛳️ Requirements

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

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

• At least 3 years of experience in sponsor or CRO clinical research project/clinical operations management.

• Proven ability to successfully manage all aspects of sponsor/CRO clinical trial management, as well as the capability to mentor and oversee the activities of other Clinical Operations Managers.

• In-depth knowledge of Good Clinical Practice guidelines and applicable 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 skills in leading and managing multidisciplinary teams within a clinical research environment.

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

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

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

🏝️ Benefits

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

• 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).

• Access to an in-suite exercise and relaxation room.

• Monthly fun events (e.g., team-building activities, games, charitable events, potlucks, picnics).

• Flexible and remote work schedules.