- Experience Level
- Entry level
As a CEVA Specialist you will provide management and service delivery excellence of (Clinical Event Validation and Adjudication) CEVA, OGM (Oversight Group Management) projects, covering single or multiple CEVA-OGM functions, with supervision from project oversight. You will provide administrative coordination for Oversight Groups (Data Monitoring Committees, Safety Monitoring Committees and Steering/Advisory Boards), provide leadership and accountability for all aspects of assigned projects.
• Manage customer interface and communication for assigned projects. Represent Clinical Event Abjudication (CEVA) on assigned projects as primary point of contact within CEVA for all internal and external customers. Liaise between internal/external customers inclusive of members.
• Manage customer deliverables for assigned projects with minimal support.
• Ensure Tactical, day-to-day leadership at project level. Responsibilities include project planning (i.e., timelines, deliverables, 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.
• Ensure compliance to IQVIA high quality standards and work within a matrix framework to achieve project and customer deliverables.
• Collaborate with CEVA Management to achieve departmental goals.
• Manage realization/profitability for assigned projects under guidance from CEVA project oversight.
• Attend meetings with internal and external stakeholders and provide project status updates. Define processes, and project planning/strategy. Provide feedback to CEVA project oversight resource and Line manager on any challenges/issues and successes.
• Contribute in audits and inspections for assigned projects.
• Track and document project progress at all project phases (start-up, operations and close-out) and identify risks and develop mitigation plans.
• Work closely with CEVA project oversight and/or Line manager to address problem areas and customer needs.
• Bachelor's Degree in Life Sciences or other directly related field or equivalent combination of education, training and experience
• 1 year of experience in project management would be preferred
• Cinical trial knowledge and basic knowledge of applicable global, regional, local clinical research regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, Standard Operating Procedures (SOPs).
• Excellent written and verbal communication skills.
• Ability to meet deadlines, manage competing priorities and changing demands.
• 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.
• Willingness and aptitude to learn new skills across CEVA service lines.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.