This is a Remote Role in North America

　　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 Clinical Event Adjudication (CEVA) lead during trial start up on event reporting and endpoint critical variables / data critical to the adjudication process as needed.

　　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.;

　　Query for potential missed events utilizing trigger report as assigned. Query site(s) for any suspected event(s) identified during the review of source documents received from the site(s) as assigned.

　　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.

　　Provide support 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. Participate in discussions regarding new business opportunities with existing customers.

　　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.;

　　Assist in the establishment and improvement of new and existing processes related to project support.

　　Contribute during audits and inspections for assigned projects. Support the CEVA Lead in the compilation of Corrective Action Plans.

　　Apply specialist expertise in aligned areas and mentor developing specialists within the CEVA department. Provide training/mentoring to new team members and participate in continuous improvement of all departmental processes and procedures by identifying and implementing efficiencies in workflow and/or case processing or review

　　Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs 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 and clinical trial knowledge; or equivalent combination of education, training, or experience.

　　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.

　　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.

　　Good knowledge of medical terminology.

　　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.

　　IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

　　We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

　　IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

　　The potential base pay range for this role, when annualized, is $78,500.00 - $117,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

　　IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

　　To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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