Global Study Management (Senior) Associate (Global CTA)
New
J
JobgetherBiotechnology, Pharmaceutical, CRO
AustraliaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- At least 3 years of clinical research experience
- Required Skills
- Project CoordinationMicrosoft ExcelPowerPoint
Requirements
- Bachelor’s degree or higher in a scientific or healthcare-related discipline.
- At least 3 years of clinical research experience within the biotechnology, pharmaceutical, or CRO industry.
- Solid understanding of clinical operations methodologies and study processes.
- Knowledge of clinical research regulations and ICH-GCP guidelines.
- Strong proficiency with Microsoft Office, particularly Excel, PowerPoint, and Project.
- Strong organizational and project coordination skills for managing multiple activities and deadlines.
- High attention to detail and commitment to quality and documentation standards.
- Analytical ability to interpret study metrics and support decision-making.
- Ability to work effectively in a global, multicultural environment.
- Proactive and results-oriented mindset with initiative for process improvement.
Responsibilities
- Support the Global Clinical Study Manager with global study delivery, ensuring delegated activities meet quality, timeline, and budget requirements.
- Coordinate cross-functional Clinical Study Team meetings and maintain collaboration with global stakeholders.
- Support study setup and maintenance across systems including eTMF and CTMS.
- Assist in the review of protocols, informed consent forms, investigator brochures, and other clinical study documentation.
- Track key study metrics such as screening, enrollment, biological samples, and protocol deviations.
- Support study drug forecasting, vendor selection, budget administration, and invoice tracking.
- Contribute to process improvement projects and provide mentoring to junior colleagues.
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