CEVA Manager - (R1031373) in Research Triangle Park, NC at IQVIA™

Date Posted: 6/22/2018

Job Snapshot

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.


PURPOSE The Associate Clinical Reviewer provides a supporting role to the project lead in the development, coordination and implementation of the management of the clinical endpoint adjudication process for clinical trials conducted by CEVA, under the guidance of a Senior Clinical Reviewer.
RESPONSIBILITIES Assist the project 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 under the guidance from a Senior Clinical Reviewer.
 Assist the project lead on the clinical aspects of project processes in the development of documents, forms, and workflows as indicated by the project under the guidance of a Senior Clinical Reviewer.
 Support the project lead in clinical processing training for team members.
 Support project lead in collection of project metrics related to clinical processing.
 Identify potential missed events when there is evidence that an additional event occurred in combination with reported event(s).
 Query site(s) for any suspected event(s) identified during the review of source documents received from the site(s).
 Provide clinical judgment during the review of documents to determine if the existing information is sufficient for the reported clinical endpoint to be adjudicated under the guidance of a Senior Clinical Reviewer.
 Participate in continuous improvement of all departmental processes and procedures by identifying and implementing efficiencies in workflow and/or case processing.
 Use the Electronic Endpoint Adjudication System or other related systems for tracking, running reports, or viewing EAC related data.
 Participate in team meetings and provides feedback on challenges / issues and successes.
 Ensure compliance to IQVIA high quality standards and works with the Project Lead to achieve project and customer deliverables.
 Contribute to achievement of department goals e.g. utilization realization and productivity metrics.
 Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed within timelines and documented. Ensure individual training plan training transcript reconcile.

Job Requirements

 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, Quintiles Standard Operating procedures (SOP).
 Working knowledge of CEVA service lines; willingness to increase knowledge across CEVA service lines and develop new skills.
 Excellent team management and leadership skills (e.g., motivational, conflict management, collaborative, organizational, and delegation).
 Strong project management skills (e.g., planning, organizational skills, strong presentation skills, report writing skills, and customer focus skills.
 Effective verbal and written communication skills including ability to network and lead teleconferences.
 Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
 Ability to deliver on multiple projects and manage competing priorities.
 Ability to manage ambiguity.
 Effective business focus, marketing, and sales skills.
 Ability to achieve results through communication, facilitation, and negotiations in a matrix service delivery environment with shared accountabilities.
 Independent judgment, negotiating, decision-making, and problem solving skills.
 Effective business acumen and financial analytical skills, tactical planning, and budgeting.
 Cross trained in a minimum of two CEVA service lines.
 Ability to handle multiple projects with competing deadlines.
 Customer focused with effective relationship building skills.
 Bachelor’s degree in health science or other directly related field and a minimum of 5 years of experience in CEVA (endpoints, DMC/DSMB, Core labs, Advisory boards); or equivalent combination of education, training, or experience.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Job ID: R1031373