Job Overview
In accordance with the process of designing and launching global clinical research studies, perform an independent QC review and ensure study set-up process and procedures are adhered to during the start-up and amendment phase; review of source documentation and database configuration versus sponsor protocol; provision of guidance in the design and organization of project components; develop and maintain best practices within the organization.
Essential Functions
• QC of project database(s) and requisition forms versus the sponsor protocol and sponsor specific requirements.
• Cross functional collaboration to ensure QC reviews reflect current process and quality standards.
• Work with Set-up Managers and/or Project Managers and/or Set-up Coordinators to resolve problems or quality findings established during the QC review.
• Oversee and maintain adherence to QC timelines to ensure client needs are met.
• Analyze and identify quality trends and opportunities for training and process improvements.
• Collaborate with QC counterparts to ensure global consistency in the study set-up process.
• Participate in external and internal audits as required.
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
Qualifications
• Bachelor's Degree in Life Sciences related field, ideally
• Minimum 4 years of clinical or research industry experience, including 1 year Set-up related, Project Management and/or Quality Control experience.
• High attention to detail as demonstrated through a track record of achievement in the role of Set-up Manager, Senior Set-up Specialist, Project Manager or equivalent.
• Knowledge of Set-up Management and/or Project Management processes and terminology would be beneficial.
• Excellent written and verbal communication skills including good command of the English language.
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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