Cynthia Lear Email and Phone Number

Senior Clinical Trial Manager at ICON plc

Responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the Client to ensure the Global Research Operations deliverables are met. Accountable for the execution of the clinical operations strategy on the project.

Responsible for the implementation and management of large to highly complex clinical trials and leading multidisciplinary cross-functional project teams from study startup through final project deliverables. Provide operational and technical assistance to support the development and implementation of key projects as well as timely delivery of key study deliverables on assigned projects. Generates and provides input on project timelines, capacity and budgets. Prepares study and risk management plans. Serves as primary study contact between Mapi and project sponsors. Tracks and reports study progress to internal and external clients. Participates in bid defense opportunities representing Clinical Operations. Leads and participates in departmental process and quality initiatives for North America and EU. Responsible for the development and updating of department SOPs to global standards. Led the development of Mapi’s Clinical Monitoring Program and provides functional management over all levels of Mapi CRAs. Functional management of in-house and contract Clinical Operations Staff which includes hiring, training, evaluating and mentoring. The Senior Group Leader operates with a high degree of autonomy and decision authority and is a point of contact for all levels from the cross-functional areas.

Responsible for performing site management activities for assigned studies to ensure integrity of the data and study specifications according to GCPs and relevant regulations. May serve in a lead role to provide clinical and technical support to the study team. Generally will be assigned to larger medium to highly complex studies and may be assigned to more than one sponsor and more than one project depending on business needs.