CEVA Specialist - (R1043080) in Research Triangle Park, NC at IQVIA™

Date Posted: 9/11/2018

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.

Description

PURPOSE
Responsible for management and service delivery excellence of small to medium sized CEVA (Clinical Event Validation and Adjudication) projects, as assigned by CEVA management, covering single or multiple CEVA functions. 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, DSMB administration, and steering committee administration.
RESPONSIBILITIES
 Manage customer interface and communication for assigned projects with minimal guidance from senior staff. Represent CEVA on projects and serve as primary point of contact within CEVA for all internal and external customers, as assigned.
 Manage customer deliverables for assigned projects with minimal guidance from CEVA management. Tactical, day-to-day leadership at project level. Responsibilities include project planning (i.e., timelines, deliverables, resourcing, central filing, and archiving records), defining / defining project scope, and quality management, with minimal guidance from CEVA management.
 Develop, finalize, and distribute of all project-specific CEVA documents and design all necessary programmed reports and listings under guidance of CEVA management as needed.
 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 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.
 Manage realization/profitability and revenue recognition for assigned projects. Work closely with CEVA management to update financial systems, invoicing, project budget review, project financial analysis, and pursuit of change orders.
 Apply specialist expertise in aligned areas.
 Attend meetings with internal and external stakeholders. Provide project status updates; define processes, and project planning/strategy. Provide feedback to CEVA management/line manager on any challenges/issues and successes.
 Work with Sales and Proposals to ensure rapid, seamless, tailored responses to opportunities. Drive business growth by improving customer loyalty through enhanced customer relations and service delivery excellence.
 May assist with sales activities such as sales presentations and proposal development (e.g., capabilities, bid defenses, strategy, costs and text, as needed under guidance of senior team member.
 Participate in audits and inspections for assigned projects. Liaise with Quality Assurance staff and management in the compilation of corrective action plans.
 Work closely with senior team members to address problem areas and customer needs.
 Read and acknowledge all necessary Quintiles 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

Job Requirements

JOB DESCRIPTION
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
 Good 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.
 Willingness to increase knowledge across CEVA service lines and develop new skills.
 Effective verbal and written communication skills including ability to lead teleconferences and face-to-face meetings.
 Proven collaborative, organizational and delegation skills.
 Ability to work on multiple projects and manage competing priorities.
 Ability to manage ambiguity.
 Accountability, ownership and transparency.
 Demonstrate independent judgment, decision-making, and problem solving skills.
 Creative and innovative, initiative and proactive.
 Customer focused with effective relationship building skills.
 Effective motivating, influencing and conflict resolution skills.
 Good presentation skills.
 Ability to establish and maintain effective working relationships with coworkers, managers, customers.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
 Bachelor’s degree in health science or other directly related field and 1 year of experience in CEVA (endpoints, DMC/DSMB, Core labs, Advisory boards); or equivalent combination of education, training and experience.
EEO Minorities/Females/Protected Veterans/Disabled

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: R1043080