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.
• 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

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.