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data analysis gcp ich medical monitoring protocol development📋 Description
- Lead scientific aspects of clinical protocols
- Lead the clinical trial team as Clinical Scientist
- Guide medical monitoring and interpretation with Clinical Research and Pharmacovigilance
- Develop Protocols and ICF documents; coordinate with Clinical Operations
- Ensure CRF design aligns with the Protocol with Data Management
- Monitor data quality, completeness, and trial integrity
🎯 Requirements
- Master’s in life sciences + 3 yrs clinical drug development OR PhD/PharmD/RN
- Solid knowledge of GCP and ICH regulatory requirements
- Ability to manage multiple priorities with planning and prioritization
- Strong analytical skills to interpret trial data and synthesize conclusions
- Proficient in designing studies and authoring documents (MMPs, SAPs, CSRs)
- Experience interacting with stakeholders across Clinical Development; oncology preferred
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