Records Management Intern at IQVIA
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 document management activities to ensure quality documents are filed in the electronic Trial Master File (eTMF).
Job Description
The role will involve 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. You will also work with both internal and external teams to ensure good communication regarding documentation processing, as well as assist 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.
This is an initial 3-month internship, with a view for further extension upon business requirements. The start date is 15th September 2025.
Key Responsibilities:
- Updates respective database(s) as documents are received by respective team members.
- Assists in saving site documents to the shared (G) drive and files using filing conventions.
- Documents study challenges and effectively communicates those to the Associate, Lead, and/or Manager.
- Assists the Specialists, Leads, and Managers with reports as needed.
- Copies and assembles documents as required.
- Conducts all activities according to appropriate IQVIA Biotech and/or sponsor SOPs.
- Undertakes filing of documents into the eTMF in Investigator Site File folders.
- Performs ALCOA-C review of documents, as applicable.