Business Operations Coordination - Sponsor Dedicated

Support CSC team members and Business Operations Management in the following trial specific activities: Quality Reviews, virtual trial master file uploads, document routing, study close-outs, reconciliation reports, data collection, change management, and various CSC related activities.

Responsabilities and Tasks:

• Work in a team environment to select and complete various CSC related tasks from a central ticketing system.
• Perform Quality Reviews for clinical studies.
• Perform document checks and uploads in vTMF (trial master file) systems).
• Assist with study close-outs and study reconciliations.
• Perform various data collections and metrics reporting.
• Assist with change management efforts.
• Perform additional standard-work tasks per CSC work instructions and SOP’s.
• Autonomy to onboard associates, delegate tasks, and resolve process related issues.
• Act as a Change Control owner.
• Act as a Non-Conformance / Quality Incident owner.

Requirement:

• A university degree or equivalent work experience is required. 
• At least 3 years operational experience in clinical trials with a pharmaceutical company and/or a CRO is preferred. 
• Prior experience with Clinical Trial supply management preferred.
• Knowledge in drug development, global clinical operations, and strategic planning is preferred.
• Good understanding of the therapeutic areas
• Strong understanding and experience with information systems (e.g. SAP, Clinical Trial Management Systems, Procurement Systems) and financial and contract management aspects of conducting clinical trials is preferred.
• Experience with Microsoft office packages Word, SharePoint, Outlook and PowerPoint is required.  Strong understanding and experience with Microsoft Excel is preferred - special emphasis on utilizing Excel spreadsheets to solve business inquiries.
• Planning and tracking skills, able to see the big picture, well organized, focused on results, customer focused, capable of managing multiple projects, excellent time management with respect to priorities and self-management.
• Must work well in a dynamic environment and be able to prioritize and respond to changing needs of the business. Individual provide service should work limited oversight and handle multiple projects simultaneously. Must be team-oriented. 
• Position requires global interaction; ability to work virtually with business partners is required.
• Travel is less than 10%.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.