- Analyze and interpret medical results, including vital signs, clinical laboratory values, adverse events, ECGs, diagnostic procedures, and pharmacodynamic endpoints.
- Compile and write Phase I and Phase II clinical trial documents, including clinical study reports, stand-alone safety narratives, and synoptic CSRs.
- Review study results to assess whether safety objectives and endpoints were met, and accurately reflect the results in safety text.
- Perform peer quality control of safety text before its inclusion in clinical study reports.
- Review reports for completeness and accuracy, and recommend changes or rewrite text as appropriate.
- Lead report delivery as part of a multidisciplinary scientific team, ensuring quality and on-time delivery.
- Review editorial comments before incorporation to ensure report text is accurate and supports the objectives and endpoints.
- Ensure deliverables comply with applicable regulatory standards, including Good Clinical Practice and International Conference on Harmonisation guidelines, and client specifications.
- Use WebEx, Veeva, Microsoft 365, SharePoint, and SmartSheet to work with international teams.
- Lead project-related client communication and interact with internal departments.
SharePoint