Senior 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.
• Lead oversight committees (Steering/Advisory Committee, Core Laboratory) as required per customer.
• Manage customer interface and communication for assigned projects.
• Manage customer deliverables for assigned projects, with minimal support on trials only.
• 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.
• 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.
• Develop and provide project-specific CEVA process training to CEVA team members, monitors, and investigative site personnel, as appropriate with support and guidance.
• Manage realization/profitability and revenue recognition for assigned projects.
• 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.
• Apply specialist expertise in aligned areas and mentor developing specialists within the CEVA department with support and guidance.
• Identify problem areas within the event adjudication process, working with CEVA project and program managers to develop and implement solutions.
• Participate in providing historical perspective and input on clients' customers and processes, to CEVA project and program managers.
• Manage newer customers with complex project requirements.
• Attend meetings with internal and external stakeholders.
• Drive business growth by improving customer loyalty through enhanced customer relations and service delivery excellence with support and guidance.
• Participate in sales activities such as sales presentations and proposal development (e.g., capabilities, bid defenses, strategy, costs, and text).
• Contribute during audits and inspections for assigned projects.
• Perform CEVA project meeting management including logistics planning and conduct, with support and guidance.
• Serve as back-up for other CEVA Leads as assigned.
• Streamline existing processes using Lean practitioner methods and develop tools to simplify processes helping increase efficiency and productivity.
• Under the guidance of project, program or CEVA management, establish mutually agreed upon working practices with customer, for standardized implementation across projects.

Qualifications and Skills

• 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.
• 5 years Clinical Research Experience.
• Previous customer-facing experience essential.
• Critical thinking.
• Project management skills.
• Initiative taking.
• In-depth knowledge of applicable global, regional and local clinical research regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, IQVIA Standard Operating Procedures.
• Willingness to increase knowledge across Clinical Event Adjudication (CEVA) service lines and develop new skills.
• Strong prioritization (critical timelines), planning and organizational skills.
• Excellent 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.
• Ability to manage ambiguity.
• Strong presentation (independently present at internal/external meetings) skills, report writing skills and customer focus skills.
• Accountability, ownership and transparency.
• Demonstrates independent judgment, negotiating, decision-making, and problem-solving skills.
• Gain knowledge of business acumen and financial analytical skills, tactical planning, and budgeting.
• Creative and innovative, demonstrates initiative and is proactive.
• Cross-trained in a minimum of two CEVA service lines.
• Ability to handle multiple projects with competing deadlines.
• Effective motivating, influencing and conflict resolution skills.