Clinical Files Specialist (CTA BackUp - Entrylevel position)

IQVIA; Municipio de Esquel; Hybrid; ARS 10,580,000 - 13,754,000; Full time

Job summary

IQVIA is seeking an entry-level Clinical Files Specialist to support Trial Master File delivery and daily administrative tasks with CRAs and RSU teams. This role emphasizes accurate document handling, regulatory support, and teamwork across project timelines.

In a hybrid setup, you will gain hands-on experience with TMF processes, study documentation, and data flow while building strong English communication and office software skills at IQVIA.

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.
• Location of hire: Bogota, Colombia
• 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.

Responsibilities

• 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.

Skills

English communication

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.
• Location of hire: Bogota, Colombia
• 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.