Clinical Files Specialist (CTA BackUp - Entrylevel position)

IQVIA LLC; Bogotá ciudad; Ibrido; COP 8.969.000 - 11.958.000; Tempo pieno

Descrizione del lavoro

IQVIA LLC is seeking an entry-level Clinical Files Specialist in a hybrid role in Buenos Aires, Argentina. You will support TMF updates, regulatory documentation, and archival processes under supervision, helping ensure trial compliance and timely delivery.

The role requires a life sciences or healthcare degree, 1–2 years of admin or intern experience in clinical research or pharma, and strong English communication, MS Office skills, and organizational abilities.

Competenze

• Bachelor degree in Life Science or Healthcare.
• 1–2 years admin support or intern in clinical research/pharma.
• Hybrid office availability in Bogota, Colombia.
• Written and verbal English proficiency.
• Proficient with MS Word, Excel and PowerPoint.
• Strong time management and organization.
• Ability to build effective working relationships.
• Awareness of GCP and ICH guidelines.

Mansioni

• Assist CRAs and RSU in updating and maintaining the TMF.
• Support regulatory documentation activities.
• Handle filing, archiving and distribution of clinical docs.
• Periodically review study files for completeness.
• Assist with Clinical Trial Supplies tracking and distribution.
• Track and manage CRFs, queries and data flow.

Conoscenze

English (verbal/written)

Time management

Organizational skills

Communication skills

Formazione

Bachelor Degree in Life Science or Healthcare

Strumenti

Microsoft Word

Microsoft Excel

PowerPoint

Descrizione del lavoro

## Clinical Files Specialist (CTA BackUp - Entrylevel position)Apply: Buenos Aires, Argentina: Full time: Posted Today: R1573525**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.comIQVIA 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.