• Oversee clinical operations management activities. • Define and monitor project scope, timelines and deliverables from project initiation to close-out. • Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation. • Oversee trial-related activities. • Track and approve vendor payments. • Provide expert advice in the design, writing and/or review of all project-related essential documents. • Develop and manage multidisciplinary project team members. • Organize, plan for, and produce minutes for project team meetings. • 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. • 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 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 appropriately documented. • Manage contracted deliverables for external committees. • Oversee SAE process and assure execution of safety plans. • Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites. • Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required. • Provide feedback to study sites on tracing and quality issues, as required by project. • Manage and conduct Endpoint and Specialty Services CPC Core Lab activities. • Provide operational support for the biostatistics and programming deliverables.