01 Aug
|
Lead Group
|
Australia
01 Aug
Lead Group
Australia
Our client is a quick-growing healthcare technology business using data, research, and innovation to support high-quality clinical evidence for regulatory submissions and publications. They work with a strong culture of ownership, trust, and delivery — and we’re looking for a Clinical Data Delivery Lead to help drive their studies end-to-end.
Up to $150,000 + super, depending on experience.
The Role
You’ll lead the delivery of clean, analysis-ready clinical datasets and partner closely with teams across Clinical, R&D;, Tech, and Regulatory.
Key Responsibilities
- Lead study data delivery using SOPs, governance, and best practices
- Manage secure data flow, storage, and reporting across clinical systems
- Oversee EDC/data platforms, data transfers, snapshots, and reconciliation
- Execute data cleaning to ensure accuracy and consistency
- Support key documents (DMPs, specs, study reports, submission support)
- Improve internal processes, reporting, and documentation
About You
- 5+ years in clinical data management and/or analytics (healthcare/biotech/medtech ideal)
- Strong skills in Python and/or R
- Experience with EDC or similar clinical data systems (AWS/S3 a plus)
- Knowledge of SOP environments, standards, and terminology
- Familiar with FDA/TGA, ICH GCP, CDISC, FHIR (bonus: SOC2/HIPAA/GDPR/21 CFR Part 11)
- Ability to work outside of typical office hours for collaboration between the USA and Western Australia. (Typically until 6-7 pm US PT / from 7-8 am AWST 3 days a week)
Why Join?
✅ Fully remote flexibility
✅ High ownership + meaningful impact
✅ Work with global stakeholders and cutting-edge research programs
Interested? Apply now or email me for a confidental discussion about the role
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📌 Clinical Data Manager (Australia)
🏢 Lead Group
📍 Australia