Daniel Izeze Email & Phone Number

United States

• Ensured that all CRO assigned to clinical studies performed and all tasks were completed in compliance with all relevant laws, regulations, and regulatory guidelines • Participated as a Global Clinical Trial Representative in cross-functional teams such as the Case Report Form Review Team, Clinical Trial Team and CROs• In the Study Concept, Planning and Strategy Phase, I worked on the regional study feasibility process, the initial assessment of all vendors, supplies planning and the development of study specific documents and timelines as required.• Scheduled weekly DM meeting with CRO vendor to discuss Data trends and issues• Worked with CRO and all Vendors on tasks assigned to ensure highly data quality.• Provided protocol specific training to CRO DM team and tracked all activities according to the procedures • Generate and resolve data queries. Update, correct, and review data in the clinical database based on resolved data queries and generate manual queries according to procedures.• Performed data tracking and reviewing for in-house review through use or creation of CRF tracking sheets. Performed in-house review of CRF for adherence to protocol requirements and project specific. • Ensured User Acceptance Testing (UAT) is carried out and documented. Highlighted any issues and brings to resolution. Monitors discrepancy management to ensure appropriate quality of data by regular checks during study conduct versus the Data Quality Plan

United States

• Provided timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data.• Ensured CRF data resolutions were managed consistently, efficiently and timely in order that databases could be declared clean and locked according to strict performance standards. • Reviewed and contributed to the development of the trial validation plan related documents and created/approved final CRF design, validation checks and reports.• Reviewed and contributed towards the preparation of protocols, crf’s and prepared and/or reviewed/contributed towards operations manuals. • Supported and assisted Clinical Data Managers, and/or Clinical Data Assistants for allocated EDC and outsourced trials.• Performed Integration of external electronic data such as lab data, PK data, IVRS and ECG data with clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database QC audits, • Developed Clinical Data Management study documentation including Case Report Form and CRF Completion Guidelines, database design, validation specifications and Data Management Plan. • Involved in execution of user testing of study-specific systems and applications. (UAT)• Performed and oversight of data processing activities including CRF tracking and data entry • Routinely interact with cross-functional team members.• Identify complex checks that are non-standard and contribute to logic check definition with understanding of analysis plan content. • Developed database specifications to facilitate the collecting, processing and reporting for lab data. • Review and contribute to database design specifications and assure all data fields are captured and validation checks are complete. Assist in database design and build activities• Ensured that all clinical study data captured and maintained by external vendors are incorporated into the study database.