Study Start-up Manager, Colombia

hace 5 días

Bogota, Colombia Novasyte A tiempo completo

Unleash Your Potential

It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward.

Join IQVIA and see where your skills can take you.

BASIC FUNCTIONS:
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 mínimal 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

LI-RW1

LI-Remote

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

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