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Senior CEVA Specialist

Aplica ya
Mapa de ubicación: Bratislava, Slovakia Full time R1236156

Descripción del trabajo

As a Senior CEVA Specialist you will provide management and service delivery excellence of projects, as assigned by Clinical Event Validation and Adjudication (CEVA) management, covering single or multiple EAM (Endpoint Adjudication Management) and OGM (Oversight Group Management) projects. 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, Image Review Committee coordination, Data Monitoring Committee administration, Safety Monitoring Committee administration and Steering Committee/Advisory Board administration, where relevant.

Main responsibilities:

  • Lead Endpoint Adjudication Committees in conjunction with Core Laboratory coordination, Image Review coordination, Data Monitoring Committee administration, Safety Monitoring Committee administration and Steering committee/ Advisory Board administration with support and guidance, where relevant.

  • Lead oversight committees (Steering/Advisory Committee, Core Laboratory).

  • 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.

  • Manage customer deliverables for assigned projects, with minimal support on trials only. Tactical, day-to-day leadership at project level. Responsibilities include project planning, defining project/scope management, quality management, and project financial management under guidance of CEVA Management.

  • Develop, finalize, and distribute all project-specific CEVA documents and design all necessary programmed reports and listings.

  • 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.

  • Upon customer approvals, locate and contract committee members. Onboard committee members and train them on their roles and responsibilities.

  • Manage realization/profitability and revenue recognition for assigned projects. Responsible for updating financial systems, invoicing, forecasting project budget review, project financial analysis.

  • Provide leadership and structure for customer service interface from scoping stage, through proposal generation, bid defense to service delivery.

  • Apply specialist expertise in aligned areas and mentor developing specialists within the CEVA department with support and guidance where relevant.

  • Identify problem areas within the event adjudication process, working with CEVA project and program managers to develop and implement solution, where relevant.

  • Participate in sales activities such as sales presentations and proposal development.

  • Serve as back-up for other CEVA Leads as assigned.

Qualifications:

  • Nursing Degree or Bachelor's degree in life sciences or educational equivalent in health science and clinical trial knowledge.

  • At least 2 - 3 years of prior relevant experience.

  • 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.

  • Willingness to increase knowledge across Clinical Event Abjudication (CEVA) service lines and develop new skills.

  • Strong prioritization, planning and organizational skills.

  • Effective verbal and written communication skills including ability to work and lead teleconferences.

  • Effective collaborative, organizational and delegation skills.

  • Independently work on multiple projects and manage competing priorities.

  • Gain knowledge of business acumen and financial analytical skills, tactical planning, and budgeting.

  • Demonstrates independent judgment, negotiating, decision-making, and problem solving skills.

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.

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