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CEVA Specialist

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

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

Provide management and service delivery excellence of small sized CEVA (Clinical Event Validation and Adjudication) projects, as assigned by CEVA management, covering single or multiple CEVA functions, with supervision from senior staff. May also provide leadership and accountability for certain aspects of larger CEVA projects as assigned by CEVA management, working cross-functionally and across the opportunity lifecycle 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 under guidance from senior team members. Represent CEVA on projects; serve as primary or back-up point of contact within CEVA for all internal and external customers, as assigned.
  • Manage deliverables for assigned projects under guidance from senior team members. Tactical, day-to-day leadership at project level. Responsibilities include project planning (i.e., timelines, deliverables, resourcing, central files, and archiving records), defining / managing project scope, and quality management under guidance from senior team members.
  • Develop, finalize, and distribute all project-specific CEVA documents. Design all necessary programmed reports and listings under the guidance of CEVA management.
  • 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 and under the supervision of senior team members.
  • Receive, triage, review and process data from various sources on time, within budget to meet quality standards. Perform data entry for tracking, generation of queries pertinent to endpoints, perform quality control and/or second level review of endpoint dossiers, assist with reconciliation, drive case closure, coordinate translations, and ensure reports are sent to the customer within assigned deadlines.
  • Ensure compliance to Quintiles high quality standards and work within a matrix framework to achieve project and customer deliverables.
  • Execute administrative tasks as required.
  • Collaborate with CEVA team members to achieve departmental goals i.e. understand quality document management and assist in the achievement of productivity, utilization, and realization metrics.
  • 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 for assigned projects under guidance from senior team members. Work closely with senior team members to update financial systems, including revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders.
  • Develop specialist expertise in aligned areas.
  • Attend meetings with internal and external stakeholders under guidance of senior team members as needed. Provide project status updates; define processes, and project planning/strategy. Provide feedback to senior project oversight resource and line manager on any challenges/issues and successes.
  • Drive business growth by improving customer loyalty through enhanced customer relations and service delivery excellence as guided by senior team member.
  • May assist with sales activities such as sales presentations and proposal development (e.g., capabilities, bid defenses, strategy, costs and text) 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 timeline and documented. Ensure individual training plan and training transcript reconcile.


REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Working knowledge of CEVA services. Familiarity with functionality of the Endpoint Tracking Database.
  • Basic knowledge of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
  • Ability to meet deadlines; manage competing priorities and changing demands.
  • Sound organization and time management skills.
  • Ability to follow instructions/guidelines, work independently, and on own initiative.
  • Attentiveness to detail and accuracy and ability to maintain high quality standards.
  • Demonstrate effective IT skills.
  • Effective written and verbal communication skills.
  • Ability to be flexible and receptive to changing process demands.
  • Willingness and aptitude to learn new skills across CEVA service lines.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.


MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's degree or educational equivalent in health science or other directly related field and ideally 1-2 years of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc).


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

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

We invite you to join IQVIA™.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Job ID: R1084418

CEVA Specialist

Dublin
Full Time

Published on 08/01/2019