bahareh beshavardi

• Accountable for all complex cancer and Rare disease study deliverables in terms of quality & delivery to plan whilst in compliance with SOPs and regulatory guidelines
• Responsible for all elements of the Data Management Lifecycle: the data collection strategy, medical coding, data validation, discrepancy management, batch analysis, database modelling & management and data transfer supporting all internal and external audit and monitoring activity
• Responsible for the clinical data review of multiple studies across both cancer and rare disease therapeutic fields  with the ability to easily change priorities and studies as necessary
• Ensure data readiness for essential milestones including interim and final analysis, with relevant documents to support submissions.
• Responsible for review of participant level data across a study in adherence with the Data Management Plan and for coordinating with Lead Clinical team for study level review as appointed.
• Review tasks to ensure it satisfies both inclusion and exclusion criteria of the study and interpretive analysis
• As per study protocol, design, review CRFs and e-CRFs and ensure the database designed and build reflects the eCRFs, understanding how different field/CRFs interact and how data collection impacts analysis.
• Create and use data review best practices and associated data review tools to identify trends and any safety signals.
• Review study protocol deviations and ensure they are correctly and consistently reported and captured in the database
• Designing, developing and building databases using EDC tools such as in OpenClinica and Redcap 

Msc in Clinical Drug Development

Bsc in Pharmacology