Charles Okezue

• Lead day-to-day clinical data management activities across multiple therapeutic areas, including Oncology, Immunology, and Cardiovascular studies.
• Serve as the primary data management contact for clinical trial teams, providing guidance on data collection, quality, and system usage.
• Coordinate data management activities across data collection, standards, reporting, analytics, centralized monitoring, and medical coding.
• Gather and document data collection requirements from clinical and operational stakeholders to ensure consistent implementation.
• Oversee User Acceptance Testing (UAT) for clinical data systems, including eCRFs, ePRO, and eCOA platforms.
• Manage external vendors to support timely setup and maintenance of clinical data collection systems.
• Implement Data Quality Management Plans and monitor data quality throughout the study lifecycle.
• Support clinical study reports and regulatory submissions by providing required data documentation and system outputs.
• Collaborate closely with CROs and external partners to ensure data quality, compliance, and timelines.
• Drive process improvements to streamline workflows and maintain complete Trial Master File (TMF) documentation.

• Collaborated with Lead Data Manager on complex data management tasks, contributing to the successful completion of 8 clinical trials.
• Actively participated in cross-functional project teams, providing data management expertise to optimize study timelines and quality.
• Independently managed study-specific data activities, ensuring data integrity and compliance for 5 clinical studies.
• Developed and implemented Case Report Forms (CRFs) and Edit Checks, improving data collection and cleaning efficiency.
• Provided advanced operational support for Medidata RAVE, streamlining data management processes and enhancing data quality
• Oversaw database development and data transfer, improving data consistency, accessibility, and query resolution.
• Generated ad-hoc reports, supporting data-driven decision-making.
• Collaborated with medical coding teams to ensure accurate and timely coding of adverse events
• Mentored and developed junior team members, enhancing their data management skills and knowledge.
• Initiated and implemented process improvements, increasing data management efficiency.

• Analyzed Phase I study protocols and led start-up meetings, optimizing CRF design and improving data collection efficiency.
• Conducted daily quality control checks, identifying and resolving data discrepancies to maintain high data integrity.
• Participated in sponsor CRF monitoring visits, effectively addressing queries and maintaining positive sponsor relationships.
• Developed and managed a data entry schedule, ensuring on-time data completion for all assigned studies.
• Led study close-out activities, ensuring complete and accurate data archiving within regulatory guidelines.
• Mentored data entry team, achieving 100% data accuracy and timely dose escalation data submission.
• Managed data entry schedule and led study close-out activities, reducing the time required for complete and accurate data archiving.

Enrolled

Graduate Degree