drjobs Records Management Intern - Global Study Leadership

Records Management Intern - Global Study Leadership

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Job Location drjobs

Bloemfontein - South Africa

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

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.

The role will you see 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 view of further extension upon business requirements. 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 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-C 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

  • Good software and computer skills including Microsoft Office applications including but not limited to Microsoft Word Excel and PowerPoint

  • 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 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


Required Experience:

Exec

Employment Type

Full-Time

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