CEVA Clinical Reviewer

Job Overview
In-depth knowledge of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International. Provide departmental support to Clinical Event Validation and Adjudication (CEVA) Management and project support to CEVA Project Managers/Leads. Support provided is typically broad in scope and complex. Support leadership and accountability for all aspects of assigned CEVA projects, working cross-functionally and across the opportunity lifecycle, integrating delivery into one seamless and transparent program for customers in areas of event adjudication in accordance with Standard Operating Procedures (SOPs), policies and practices.

Essential Functions
• Assist the CEVA lead in the identification of source documents needed by the Endpoints Adjudication Committee (EAC) for the trial endpoints as indicated by the needs of the project with minimal guidance of Senior specialist.
• Assist the CEVA lead on the clinical aspects of project processes in the development of documents, forms, and workflows as indicated by the project.
• Assist the CEVA lead to manage realization/profitability and revenue recognition for assigned projects. Responsible for updating financial systems, invoicing, project budget review, project financial analysis, pursuit of change orders if required.
• Collaborate with CEVA team members to achieve departmental goals i.e. understand quality requirements and assist in the achievement of productivity, utilization, and realization metrics.
• Manage the processing of CEVA data by collecting and tracking incoming data, determining initial/update status of incoming data (endpoints, etc.) and distributing event information to appropriate project personnel in the workflow for continued processing.;
• Provide clinical judgment during the review of documents to determine if the existing information is sufficient for the reported clinical endpoint to be adjudicated as per work assignment.
• Work closely with internal and / or external partners to manage development, testing, and use of electronic systems necessary for CEVA project processes.
• Develop and provide project-specific CEVA process training to CEVA team members, monitors, and investigative site personnel, as appropriate.
• Attend meetings with internal and external stakeholders. Provide project status updates, support processes, and project planning/strategy. Provide feedback to CEVA Management/ Line manager on any challenges/issues and successes.;

Qualifications
• Bachelor's Degree Nursing Degree or Bachelor's degree in life sciences or educational equivalent in health science or other directly related field and clinical trial knowledge; or equivalent combination of education, training, or experience.
• Equivalent combination of education, training, or experience
• Strong prioritization (critical timelines), planning and organizational skills.
• Effective verbal and written communication skills including ability to work and lead teleconferences.
• Effective collaborative, organizational and delegation skills.
• Independently work on multiple projects and manage competing priorities.
 

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