Job Overview

　　Provide project related assistance for assigned project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

　　Essential Functions:

　　SYSTEMS AND DOCUMENTS MANAGEMENT:

　　Registration on clinicaltrials.gov

　　Respond to ct.gov inbox inquiries

　　Sponsor specific systems management: site activation, transfer of obligations, etc

　　EDL management

　　Preparing, handling, distributing, filing, and archiving of clinical documentation and reports

　　CSR Appendices management

　　REPORTING AND ANALYSIS:

　　Assist the Study lead in providing a periodic review of the prospective principal investigators to be selected for participation in the study

　　Assist the Quality Team with Monthly Investigator Quality reviews, mitigation strategy calls and preparation of Meeting minutes

　　TEAM MANAGEMENT:

　　Day to day management of the Project Management Associate (PMA) role:

　　Provide oversight and documentation of trainings

　　Provide technical guidance

　　Perform quality control activities.

　　Qualifications

　　Bachelor's Degree Life sciences or related field

　　Typically requires Minimum 5 years of relevant experience.

　　Experience in clinical site monitoring / centralized monitoring and/or clinical report review experience

　　Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint

　　Strong written and verbal communication skills including good command of English language

　　Results and detail-oriented approach to work delivery and output

　　Good problem solving skills

　　Good planning, time management and prioritization skills

　　Good leadership skills

　　IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

　　IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

　　To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

　　EEO Minorities/Females/Protected Veterans/Disabled