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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.

• 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.

Qualifications and Skills

• Bachelor's Degree in Nursing or Life Sciences

• Experience in clinical research highly beneficial

• 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.

• Creative and innovative, demonstrates initiative and is pro-active.

• 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 clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com