Job Overview:
Responsible for collaborating with the strategic CSS in the creation and distribution of various documents and system builds to drive effective and efficient study start-up activities globally.
Responsibilities:
Responsibilities include but are not limited to:
• Survey build (Key study document list): Creation of electronic survey build based off required documents needed for study.
• Package build: Prepare and build electronic packages within our system for sites which may include essential documents, regulatory documents, etc.
• Query Tracking process: Track queries issued by regulatory bodies within our electronic system.
• Informed Consent Form (ICF) build: Create ICF template based on country requirements as received from affiliate.
• Essential Document Review: Review essential documents against checklist per country regulations.
• Completion of any other defined transactional activities, i.e., Clinical Study Report (CSR), Trial Master File Oversight.
Qualifications:
• Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required
• Competent use of Excel.
• Minimum of 1-2 years of clinical research experience and a minimum of 1+ years of study start up experience.
• Experience with ICF review
• Experience reviewing essential documents
• Experience working with IRB/IEC and competent authority submissions and approvals
• Prior experience working with Vault Clinical (or similar tracking system)
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