CEVA Clinical Reviewer

As a CEVA Clinical Reviewer you will provide departmental support to CEVA (Clinical Event Validation and Adjudication) Management and project support to CEVA Project Managers/Leads. You will 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 event adjudication in accordance with Standard Operating Procedures, policies and practices.

Main Responsibilities

• Assist Clinical Event Abjudication (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 for the trial endpoints

• Assist on the clinical aspects of project processes in the development of documents, forms, and workflows

• Tracking incoming CEVA data and distributing event information to appropriate project personnel

• Query sites for any suspected events identified during the review of source documents received from the sites. Conducts the query process according to the CEVA project escalation plan

• Maintain the blinding of patient identifiers in the provided documents to protect patient confidentiality as per HIPPA, dossier preparation as per the project specific Endpoint management plan

• Coordinate with other project support staff within and across the organization to identify and consolidate support processes

• Participate in the training of 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 and review

• 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

• Participate in audits and inspections for assigned projects

Education, Qualifications and Experience

• Nursing Degree or bachelor’s degree in Life Sciences or educational equivalent in health science

• At least 3 years of Clinical Research Experience

• Working knowledge of Clinical Event Abjudication (CEVA) services

• Good knowledge of medical terminology

• Basic knowledge of applicable global, regional, local clinical research regulatory requirements, i.e. Good Clinical Practice and International Conference of Harmonization (ICH) guidelines, SOPs.

• Ability to meet deadlines and manage competing priorities

• Effective written and verbal communication skills

• Sound organizational skills and time management skills

• Ability to follow instructions and work independently

• Ability to maintain high quality standards

• Demonstrate effective IT skills

• Ability to be flexible and receptive to changing process demands

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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.