North Sydney, Australia | Full time | Hybrid | R1545400
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 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.
* Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
* May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
Qualifications
* High School Diploma or equivalent
* 3 years administrative support experience.
* Equivalent combination of education, training and experience.
* Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
* Written and verbal communication skills including good command of English language.
* 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.
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We elevate leaders that inspire change. Being named to the PharmaVoice 100 celebrates our people's impact as trailblazers in life sciences.
We champion leadership that drives progress. Recognition in the HBA Awards celebrates our commitment to advancing women in healthcare.
Brandon Hall Group Award – Leadership Development
We invest in learning. Earning a Brandon Hall Group Excellence Award for Leadership Development reflects our commitment to equipping employees with the support they need to lead with impact.
Brandon Hall Group Award – Talent Acquisition
We build talent strategies that shape the future. Earning a Brandon Hall Group Excellence Award for Talent Acquisition reflects our commitment to attracting top-tier candidates to IQVIA.
Webby Awards – Talent Branding Recognition
We create content that connects and inspires. Recognition in the Webby Awards for Talent Branding highlights our commitment to bold, authentic storytelling that brings the IQVIA brand to life for candidates.
LinkedIn – Top Companies in Portugal
We invest in employee experience. Being named to LinkedIn's Top Companies list in Portugal reflects our commitment to building a workplace where talent thrives.
Universum (China) – Most Attractive Employers for Students
We pride ourselves in our strong reputation among university students launching their career journeys, earning a spot as of China's Most Attractive Employers for Students.
We lead with innovation and excellence, earning a place on the Fortune World's Most Admired CompaniesTM list.
Glassdoor's Best Places to Work in the UK
Our commitment to an exceptional employee experience has earned us a spot on Glassdoor's Best Places to Work UK list for 2026 — an award based entirely on authentic, unsolicited reviews from IQVIA colleagues.
MedTech Breakthrough Award
We drive transformative health solutions. This recognition by the MedTech Breakthrough Awards underscores our commitment to advancing digital innovation that improves care and outcomes worldwide.
Brandon Hall Group Awards – Learning & Development
We prioritize our people's growth. The Brandon Hall Group Excellence Awards named us a leader in creating impactful learning solutions that enhance organizational success.
We deliver insights and innovations that matter. Earning a spot on Forbes' World's Best Management Consulting Firms list shows our impact as a trusted partner for customers worldwide.
Vault Consulting APAC Top Ranked Award
We deliver expertise and measurable impact, earning a top ranking in Vault Consulting's APAC list as a partner committed to innovation and excellence for customers across the region.
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