
Clinical Trials Professional
15 hours ago
This is an exciting role to work with one of the world's leading pharma and biotech companies, helping them advance new drugs and devices.
Job Summary:The Clinical Trial Associate will play a key role in the success of our trials, providing support for the preparation of submission packages, trial and site administration, and document management.
Key Responsibilities:- Supporting with the preparation of submission packages (IRB/ERC, regulatory agencies)
- Tracking and updating study metrics, as well as setting up and maintaining TMF/eTMF, documents collection and quality check
- Liaising with clinical sites, internal and external stakeholders, and coordinating on drug supply planning, provision and destruction process, trial equipment and materials planning and management
- Coordination of vendors' activities, including printing, translation and other vendors' management
- Distribution of site materials and equipment, and organisation of meetings
- Previous clinical trial experience in the pharmaceutical or biotech industry or investigative site
- Bachelor's degree or equivalent preferred
- Working knowledge of Australian study start-up processes
- Attention to detail, passion and reliability
- Excellent communication skills
- Basic knowledge and understanding of Essential Documents, CFR and GCP/ICH
- Proficiency with technological systems (Microsoft Office, TMF, CTMS)
Our success depends on the quality of our people. We strive to build a diverse culture that rewards high performance and nurtures talent.
As part of our team, you can expect a competitive salary and a range of benefits designed to promote well-being and work-life balance.
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