We are looking for a Clinical Project Specialist to support our Australia clinical operations team.
This is a part time role supporting local Australian project work, with a focus on clinical trial administration, study coordination, document tracking, meeting coordination, and day to day project support.
Role overview
The Clinical Project Specialist will support project management activities related to clinical trial execution and daily study operations.
This role will work closely with study team members and study managers to ensure assigned study tasks are completed accurately, efficiently, and in line with applicable SOPs, ICH GCP guidelines, and regulatory requirements.
Key responsibilities
* Support clinical trial administration and project management activities
* Assist with document development, formatting, review, tracking, filing, and reconciliation
* Support clinical study operations in line with SOPs, ICH GCP, and regulatory requirements
* Assist with study binder development and distribution
* Track study specific information using databases, spreadsheets, and other tools
* Support tracking of site activity, study metrics, clinical supplies, and related study information
* Coordinate meetings, prepare agendas, take minutes, and distribute follow up notes
* Proactively identify and escalation project related issues
* Work closely with study managers and clinical project teams to support study execution
* Contribute to process improvement and quality related initiatives where required
Requirements
* Previous experience in the pharmaceutical, clinical research, or CRO environment
* Strong administrative, coordination, and document management skills
* Excellent written and verbal communication skills
* Strong Microsoft Office skills, including Outlook, Word, Excel, and PowerPoint
* Ability to prioritise tasks, work proactively, and manage multiple deadlines
* Experience with EDC, CTMS, IVRS, or eTMF systems would be advantageous
* Bachelor's degree preferred, although equivalent experience will also be considered
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