Sr. Clinical Operations Manager

We are looking for an experienced Sr. Clinical Operations Manager to join our team!

Are you well organized, but adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!

This role serves as the primary point of contact for industry sponsored clinical trials as well as any additional assigned projects.

Remote candidates are welcome to apply.

• Work closely with the Head of Research and Community Health Operations and Head of Endpoint and Specialty Services to ensure overall quality of project services, proactive issue resolution and development of systems to standardize and improve project management practices as well as the whole ARO’s efficiency.
• Serve as a mentor to other Clinical Operations Managers, including providing guidance on what efforts and activities are required to ensure the overall quality of project services and deliverables.
• Oversee clinical operations management activities when delegated to a Clinical Trial Manager (CTM). For single-site or smaller multi-center studies in which these activities are not delegated to a CTM:

• Manage site identification, evaluation, initiation, contracting/budget negotiation, and site monitoring processes as required by contract.
• Identify the required regulatory documents for investigational product (IP) release and oversee documents collection.
• Prepare central IRB submissions; oversee site IRB approvals and ensure collection of all new or expiring Investigator regulatory documents after site activation.
• Oversee the development of project-specific essential documents for site oversight and development of site materials.
• Review and finalize monitoring visit reports and follow-up letters with Clinical Research Associates (CRAs).
• Work with CRAs on overall site management including identification, and resolution of site related compliance issues.
• Prepare study enrollment reports and review site issues with the project team.
• Manage and approve site payments as applicable.
• Contribute to process improvement, including but not limited to review and/or development of SOPs, and development and/or implementation of methods to improve 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 notify appropriate designee to ensure completion and filing of training documentation.
• Oversee trial‑related activities and provide performance feedback to supervisors for all project team members.
• Participate in the review, development and testing of study databases.
• Provide investigational product or device tracking and disposition as required by project.
• Develop and manage site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services.
• Identify vendors and manage vendor services.
• Provide 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, 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 produce minutes for project team meetings.
• Proactively identify project issues, propose resolutions to the project team, applicable heads of departments, CPC executives and/or the sponsor, and then track implementation of resolution through to completion and efficacy checks.
• Ensure the overall quality of project services and deliverables.
• Provide necessary updates and reports to the sponsor as outlined by the contract.
• Plan and oversee the execution of investigator meetings as contracted.
• Work with the business development team on budgets, proposals and change orders.
• Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements.
• Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. Provide timely feedback to the Head of Research and Community Health Operations on the progress of project assignments. Routinely advise management regarding the overall project status.
• Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper.
• Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are…