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IQVIA Biotech is now hiring a Study Start-Up Specialist/Manager. Ideal candidate is experienced with completing/reviewing regulatory documents, creating and update ICFs, IRB submissions, and maintaining regulatory files as well as a strong background in project management (2-3 years).
Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) during start-up. Work with both internal and external teams to assure good communication, regarding documentation processing. Assure documents maintained are following International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients. A SSUS II may be assigned to one or more start-up projects, and typically is able to work independently on a project with minimal supervision.
Responsible for providing customer-focused leadership in the execution of operational strategy and management of start-up activities for projects or programs. This includes but not limited to the overall management and oversight of the following processes: site feasibility, regulatory approvals, and site contracts. May be assigned to manage the site start-up activities for a country, region, or global trial.
Responsible for maintaining internal tracking for study site status from initial site contact through site initiation and maintains clear client and internal team communication and documentation. This position works directly with Clinical Monitoring, Project Management and Clinical Trial Managers in setting priorities and expectations for study start-up.
MINIMUM RECRUITMENT STANDARDS:
BS /BA/BSc or equivalent in a health-related field plus 7 years of related clinical trials experience
within the total years of experience, at least 2-3 years of project lead experience is required
Equivalent combination of education, training and experience
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