Sr. CEVA Specialist

Job Overview

Provide management and service delivery excellence of projects, as assigned by Clinical Event Validation and Adjudication (CEVA) management, covering single or multiple EAM (Endpoint Adjudication Management) and OGM (Oversight Group Management) projects. Provide 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 Endpoint Adjudication Committee coordination, Core Laboratory coordination, Image Review Committee coordination, Data Monitoring Committee administration, Safety Monitoring Committee administration and Steering Committee/Advisory Board administration, where relevant.

Essential Functions

• Lead Endpoint Adjudication Committees in conjunction with Core Laboratory coordination, Image Review coordination,  Data Monitoring Committee administration, Safety Monitoring Committee administration and Steering committee/ Advisory Board administration, where relevant, as required per customer and with support and guidance, where relevant.
• Lead oversight committees (Steering/Advisory Committee, Core Laboratory) as required per customer, where relevant.
• Manage customer interface and communication for assigned projects.  Represent Clinical Event Adjudication (CEVA) on assigned projects as primary point of contact within CEVA for all internal and external customers, liaise between internal/external customers inclusive of committee members with support and guidance where relevant.;
• Manage customer deliverables for assigned projects, with minimal support on trials only. Tactical, day-to-day leadership at project level. Responsibilities include project planning (i.e., timelines, deliverables, central filing, and archiving records), defining project/scope management, quality management, and project financial management under guidance of CEVA Management, as needed.
• Develop, finalize, and distribute all project-specific CEVA documents and design all necessary programmed reports and listings relevant to CEVA Endpoint Adjudication Committee coordination, Core Laboratory coordination, Image Review coordination, Data Monitoring Committee administration, Safety Monitoring Committee administration and Steering Committee/Advisory Board administration, with support and guidance where relevant.
• Work closely with internal and / or external partners to manage development, testing, and use of electronic systems necessary for CEVA project processes, with support and guidance where relevant.
• Develop and provide project-specific CEVA process training to CEVA team members, monitors, and investigative site personnel, as appropriate with support and guidance where relevant.
• Develop, finalize, and distribute all project-specific CEVA documents, where relevant.
• Upon customer approvals, locate and contract committee members. Onboard committee members and train them on their roles and responsibilities.
• Manage realization/profitability and revenue recognition for assigned projects. Responsible for updating financial systems, invoicing, forecasting project budget review, project financial analysis, pursuit of change orders with support and guidance where relevant.
• Provide leadership and structure for customer service interface from scoping stage, through proposal generation, bid defense to service delivery, and throughout the development and commercial lifecycle of the product with support and guidance where relevant.
• Apply specialist expertise in aligned areas and mentor developing specialists within the CEVA department with support and guidance where relevant.
• Identify problem areas within the event adjudication process, working with CEVA project and program managers to develop and implement solution, where relevant.
• Participate in providing historical perspective and input on clients customers and processes, to CEVA project and program managers, where relevant.
• Manage newer customers with complex projects requirements. Serve as a Subject Matter Expert (SME) and provide guidance on focused areas and regulatory requirements as it relates to, where relevant.
•  Attend meetings with internal and external stakeholders. Provide project status updates, define processes, and project planning/strategy with support and guidance where relevant. Provide feedback to CEVA oversight and line manager on any challenges/issues and successes, where relevant.;
• Drive business growth by improving customer loyalty through enhanced customer relations and service delivery excellence with support and guidance where relevant. Participate in discussions regarding new business opportunities with existing customers.
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