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Summary

Under the guidance of the Study Site Management leadership, this position will be responsible for conducting end-to-end site start-up from feasibility to site closure serving as the primary point of contact for the site, country and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and site start-up activities, maintenance and close-out activities.

Home Based opportunity which requires German language skills.

Duties and Responsibilities

• Participate in study-specific site management meetings.
• Utilize tools to track activities and develop reports.
• Responsible for essential document collection, tracking & review.
• Responsible for the collection of country and site level intelligence.
• Responsible for Institutional Review Board/ Ethics Committee submissions for the country.
• Support Regulatory Authority submissions.
• Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a study as appropriate.
• Manage site-level Regulatory Green Light processing.
• May serve as an In-House Study Lead on limited-scope studies, a primary point of contact to study team on end-to-end study activity. May serve as In-House Study Lead at a regional or country level.
• Lead study-specific site management meetings as appropriate.
• Oversee essential document collection, tracking & review.
  

Requirements

• Preferred BA/BS degree in Business Administration, science or related field, or additional relevant experience.
• Thorough understanding of clinical research principles and process.
• Thorough understanding of FDA and/ or EU Directives and Regulations, ICH Guidelines and various country/local regulatory requirements.

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