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budgeting etmf ctms capa regulatory compliance📋 Description
- Lead operational planning for clinical studies per ICH-GCP.
- Primary client contact; coordinate invoicing with PM.
- Develop study documents (plans, ICF templates, CRFs, trackers).
- Drive site feasibility, recruitment strategy, and enrollment risks.
- Oversee IP releases, monitoring, and CAPA with QA teams.
- Ensure eTMF accuracy and data quality with PM/CRAs.
🎯 Requirements
- Bachelor\'s degree in science/health; advanced degree preferred.
- Oncology (Phase I) trial experience in Australia preferred.
- Proficient with MS Office (Outlook, Word, Excel, PowerPoint).
- Excellent communication and teamwork; detail-oriented.
- Willing to travel domestically and internationally, including overnight.
- Knowledge of ICH-GCP and regulatory requirements.
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