Sr. CEVA Specialist- Adjudication Lead

Remote role - Anywhere in US

Purpose

Provide management and service delivery excellence of projects, as assigned by CEVA(Clinical Event Validation and Adjudication)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. Represent CEVA on assigned projects as primary point of contact within CEVA for all internal and external customers; liaise between internal/external customers

• Manage customer deliverables for assigned projects.

• Tactical, day-to-day leadership at project level. Responsibilities include project planning (i.e., timelines, deliverables, resourcing, central filing, and archiving records), defining project/scope management, quality management ,and project financial management under guidance of CEVA management, as needed

• Develop, finalize, and distribute all project-specific CEVA documents and design all necessary programmed reports and listings relevant to CEVA endpoint adjudication committee coordination, core laboratory coordination, DSMB administration, and steering committee administration

• 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 leadership 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.

• 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

• Apply specialist expertise in aligned areas and mentor developing specialists within the CEVA department.

• 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.

• Participate in sales activities such as sales presentations and proposal development (e.g., capabilities, bid defenses, strategy, costs and text)as required , under guidance of senior team member.

• Contribute during audits and inspections for assigned projects. Liaise with Quality Assurance staff and management in the compilation of Corrective Action Plans.

• Address problem areas and customer needs.

• Participate in discussions regarding new business opportunities with existing customers

• Under the guidance of CEVA management, establish mutually agreed upon working practices with customer, for standardized implementation across projects.

• 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

Required Knowledge, Skills, and Abilities

In depth knowledge of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, Quintiles Standard Operating Procedures.

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.