Nusrat K Dean

Clinical Trials Data Management

• Led the end-to-end data management process for multiple clinical trials, ensuring high-quality data collection, validation, and reporting
• Coordinated the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities
• Developed and implemented Data Management Plan documents to ensure delivery of accurate, timely, consistent, and high-quality clinical data
• Worked with Third Party/External data Vendors to complete the set-up of data import and reconciliation processes
• Performed comprehensive review of all data generated from the clinical study including Third Party/External data, SAE data, and local lab data, as applicable
• Track and report metrics leading to database lock
• Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
• Supported the filing of eTMF documentation to maintain an inspection ready environment throughout the study lifecycle.

Organizational and managing skills as DOC

• Independently handled 3 allocated projects and worked as a DOC
• Assigned activity to other resources, successfully cleaned data for the IA and Database lock
• Mentored and trained junior data management staff, fostering a culture of continuous learning and professional development
• Provided reports, status updates, feedback, and advice to key study stakeholders on the progress of data cleaning and risk identification/mitigation activities
• Collaborated closely with cross-functional teams including CRAs, biostatisticians, and project managers to design and implement effective data management strategies

Clinical Trials Data Management

• Assisted in the setup and maintenance of EDC systems, ensuring accurate and efficient data capture processes
• Participated in the review and validation of clinical trial data to identify and resolve discrepancies
• Supported the development of case report forms (CRFs) and data entry guidelines in alignment with study protocols
• Generated data listings, summaries, and reports for internal and external stakeholders
• Generate, resolve and track 20-300 queries to resolve discrepant and missing data Reconciliation of third party vendor data (SAE, VENDOR, etc.)
• Independently perform data cleaning including query activity and Electronic Data Capture (EDC) Status changes, manual review, SAS listing, DM status reports, Identify and report issues and data trends.