Clinical Files Specialist (CTA BackUp - Entrylevel position)

IQVIA LLC; Buenos Aires; Hybrid; ARS 11,240,000 - 16,860,000; Full time

Job summary

IQVIA is seeking an entry level Clinical Files Specialist to join the team in a hybrid working model. You will assist CRAs and RSU in updating and maintaining TMF, regulatory docs, and trial files to ensure compliance and timely deliverables.

The role requires a Life Science or Healthcare degree and 1–2 years of admin support or intern experience in clinical research, with English communication skills and MS Office proficiency. Office location: Bogota, Colombia.

Qualifications

• Bachelor Degree in Life Science or Healthcare.
• 1–2 years administrative support or intern experience in clinical research or pharma.
• Hybrid position with office-based work in Bogota, Colombia.
• Written and verbal communication in English.

Responsibilities

• Update and maintain TMF and trial documents to track site compliance.
• Assist regulatory documentation and regulatory/start-up tasks.
• Prepare, handle, file and archive clinical documents per SOPs.
• Review study files for completeness on a periodic basis.
• Support distribution of Clinical Trial Supplies and tracking information.
• Track and manage CRFs, queries and data flow.

Skills

English proficiency

Communication skills

Time management

Education

Bachelor degree in Life Science or Healthcare

Tools

MS Word

MS 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.