Records Management, Project Leadership Intern
2 months ago
Our Records Management Interns are an integral part of our global team and work in partnership with Records management members. Your key purpose will be to support with document management activities to ensure quality documents are filed in electronic Trial Master File.
Responsible for maintaining database(s) and assisting with Records Management Unit efforts to ensure the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) throughout the clinical study. Work with both internal and external teams to ensure good communication regarding documentation processing. Assists with maintaining documents in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by the company and its clients.
ESSENTIAL FUNCTIONS:
- Updates respective database(s) as documents are received by respective team members.- Assists in saving site documents to the shared (G) drive and file using filing conventions.- Documents study challenges and effectively communicate those to the Associate, Lead and/or Manager.- Assists the Specialists, Leads and Managers with reports as needed.- Copy and assemble documents as required.- Conducts all activities according to appropriate IQVIA Biotech and/or sponsor SOPs.- Undertake filing of documents into the eTMF in Investigator Site File folders.- Perform ALCOA review of documents, as applicable.
QUALIFICATIONS AND EXPERIENCE REQUIRED:
- Completed University/College Degree, preferably in the field of science, or combination of education and experience.-
- An interest in life sciences, clinical research and/or patient health- An interest in Documents Management- Good written and verbal communication skills.- Positive attitude and ability to interact with all levels of staff.- Ability to manage multiple priorities.- Ability to use sound judgment and assess and recommend specific solutions.- Ability to work somewhat independently, prioritize effectively and work within a matrix team environment.
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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