16597-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 client 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.
• Participate in sales activities such as sales presentations and proposal development (e.g., capabilities, bid defenses, strategy, costs and text) as required to ensure rapid, seamless, tailored responses to opportunities, under guidance of  senior team members, CEVA oversight or line manager as appropriate.
• Contribute during audits and inspections for assigned projects. Liaise with Quality Assurance staff and knowledge and quality management in the compilation of Corrective and Preventive Action Plans, with support and guidance where relevant.
• Perform CEVA project meeting management including logistics planning and conduct, with support and guidance where relevant.
• 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.
• Read and acknowledge all necessary IQVIA standard operating procedures (SOPs), customer SOPs and e-Trainings as required. Ensure all required training is executed within a timelines and documented. Ensure individual training plan and training transcript reconcile.

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. Req
•  Typically requires 2 - 3 years of prior relevant experience.
• 3 years’ of experience in CEVA (EAM/OGM) - Required.
• Equivalent combination of education, training, or experience - Required.
• In depth knowledge of applicable global, regional and local clinical research regulatory requirement.
• i.e. Good Clinical Practice (GCP) and International  Conference on Harmonization (ICH) guidelines, IQVIA Standard Operating Procedures.
• Willingness to increase knowledge across Clinical Event Abjudication (CEVA) service lines and develop new skills.
• 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.
• 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 pro-active.
• 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.
• Ability to establish and maintain effective working relationships with co-workers, managers, and customers.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.