TMF & Regulatory Files Specialist (Hybrid)

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

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.