Saeeda Aijaz Email & Phone Number

Houston, Texas, United States

Lead the technical implementation of IRT systems to support clinical trial screening, randomization, and supply management. Oversee the data collection and monitoring EDC for Clinical StudiesManage the technical aspects of tablet-based questionnaires, coordinating with study teams and vendors to optimize data collection processes. Conducted detailed business analysts, outlining problems, opportunities, and solutions for the business. Developed Project Plans and Managed Project timelines, ensuring milestones were met.Facilitated meetings with stakeholders to gather requirements. Created and maintained comprehensive documentation for all projects. Analyzed business processes and systems to identify areas for improvement.Implemented process improvements that resulted in a 15% increase in operational efficiency.

Houston, Texas, United States

Initiation and coordination of clinical trial start-up activities, focusing on regulatory document preparation and submission.Manage the compilation and completion of critical regulatory documents including but not limited to form FDA 1572, Financial Disclosure forms, Site Contact Forms, delegation logs and training logs. Maintenance of Site Good Clinical Practice certifications, PI and Sub-I Licenses, Maintaining updated CVs for all Site PersonnelMaintaining Calibration Certificates and CLIA Certificates for laboratory requirementsLed quality assurance inspections to ensure compliance with GCP, Protocol and other Regulatory requirements. Maintaining ISF and Pharmacy Binders Developed and Implemented quality management systems and SOPs to enhance operational efficiency. Managed the documentation and reporting of non-compliance issues, ensuring timely resolutions.Collaborated with cross functional teams to ensure regulatory compliance in clinical operations.Provided training and guidance to staff on quality assurance and regulatory compliance.

Houston, Texas, United States

Responsible for entering all clinical data in Electronic Capture SystemManage Data Collection, Validation for several clinical trialsValidate Clinical Trial Data and Close Queries Implemented Quality Control Procedures to ensure Efficient Database OperationsConducted training for Clinical Staff on Data Management