Bahareh Beshavardi

I am a Clinical Data Manager with more than 6 years of experience, working in both clinical and biotechnology industries, in all different phases of I to III. I have been responsible and leading designing and validating clinical databases. Developing data management plans in areas such as coding, reporting, workflow or data transfer in cancer, rare disease, cardiovascular, mental health and diabetic diseases.

I have excellent communication skills, both written and verbal. My Project management skills, independence and the ability to lead a team effectively is my area of expertise.

• 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