Clinical Files Specialist (CTA BackUp - Entrylevel position)

IQVIA; Buenos Aires; Hybrid; ARS 670,000 - 1,116,000; Full time

Job summary

IQVIA is seeking an entry-level Clinical Files Specialist to support daily administrative activities alongside Clinical Research Associates and Regulatory and Start-Up teams. The role involves TMF maintenance, regulatory documentation, and archiving of clinical reports in a hybrid work setting.

Ideal candidates hold a Life Science or Healthcare degree, have 1–2 years of administrative support or intern experience in clinical research or pharma, and communicate effectively in English.

Qualifications

• Bachelor degree in Life Science or Healthcare.
• 1–2 years administrative support experience or an intern experience in clinical research or pharma.
• Hybrid position availability (office).
• Written and verbal communication skills including good command of English.
• Computer skills with Microsoft Word, Excel and PowerPoint.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of GCP and ICH guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.

Responsibilities

• Assist CRAs and RSU with updating and maintaining clinical documents and TMF.
• Assist the clinical team with regulatory documentation.
• Assist with preparation, handling, distribution, filing and archiving of clinical documentation and reports.
• Assist with periodic review of study files for completeness.
• Assist with tracking and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with tracking and management of CRFs, queries and clinical data flow.

Skills

Administrative support

English language

Time management

Organizational skills

Education

Bachelor Degree in Life Science or Healthcare

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Clinical Files Specialist - Entry Level role

Work modality: Hybrid

Job Overview

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with regulatory documentation.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.

Qualifications

• Bachelor Degree in Life Science or Healthcare.
• 1-2 years administrative support experience or an Intern experience in clinical research or pharma.
• Availability to go to the office: Hybrid position.
• Written and verbal communication skills including good command of English language.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.