Clinical Trials Documentation Specialist

IQVIA; Sydney; On-site; AUD 55,000 - 75,000; Full time

Job summary

IQVIA is seeking an entry-level Administrative Support role to assist the Clinical Research Associates (CRAs) and RSU team with maintaining trial master files and regulatory documentation. The role involves handling, filing, and archiving study documents and supporting timely project delivery.

Responsibilities include assisting with study file reviews, clinical supplies tracking, data flow, and acting as a central communications contact. Some on-site support may be required after training.

Qualifications

• Minimum 2 years administrative support experience in clinical trials.
• Proficient with MS Word, Excel and PowerPoint; strong written/verbal English.
• Knowledge of GCP/ICH guidelines as provided in company training.

Responsibilities

• Assist CRAs and RSU with updating TMF and related documents.
• Handle, file and archive clinical documents per SOPs.
• Support study file reviews for completeness.
• Coordinate Clinical Trial Supplies and tracking information.
• Track and manage CRFs, queries and data flow.
• Act as central contact for project communications and documentation.
• May accompany CRAs on site visits after training.

Skills

Written English

Communication skills

Time management

Organizational skills

Relationship building

Education

High School Diploma or equivalent

Tools

MS Word

MS Excel

PowerPoint

Job description

IQVIA is seeking an entry-level Administrative Support role to assist the Clinical Research Associates (CRAs) and RSU team with maintaining trial master files and regulatory documentation. The role involves handling, filing, and archiving study documents and supporting timely project delivery.

Responsibilities include assisting with study file reviews, clinical supplies tracking, data flow, and acting as a central communications contact. Some on-site support may be required after training.