Muhammad Syed, Pharm-D, CRPRA, CCRPS

Study Start-Up and Country Execution • Led local study start-up activities, including feasibility review, IRB submissions, site activation, and SIV readiness. • Developed site-level recruitment and patient engagement support aligned with study timelines. • Coordinated start up meetings with sponsors, CRAs, and cross functional stakeholders to ensure on-time delivery. • Maintained TMF and ISF quality, ensuring inspection readiness and compliance with study requirements. Clinical Trial Conduct and Performance Oversight • Owned site-level study execution ensuring adherence to ICH GCP, patient safety, and protocol compliance. • Managed multiple active clinical trials, driving timely data entry, query resolution, and operational performance. • Supported screening, informed consent, enrollment, and retention activities to meet recruitment goals. • Acted as primary liaison between site staff, monitoring teams, and sponsors to align study strategy and KPIs. Quality, Audit, and Close Out Leadership • Supported audit readiness, responded to monitoring findings, and implemented corrective actions as needed. • Ensured study close-out activities, including regulatory reporting, archiving, and compliance documentation. • Partnered with QA teams and sponsors to maintain high-quality standards and full PAI readiness.

COVID-19 Vaccine Obesity and Diabetes IBS

1- Examined data processing operations and supervised the proof of concept for new processes through research. 2- Established, calibrated, and upheld laboratory and field research equipment to meet the study's specifications. 3- Streamlined data management processes increase efficiency and accuracy in data collection and reporting. 4- Encoded and validated data in compliance with the specified research protocol and coding procedures, inputting the information into a computer database for subsequent analysis. 5- I drafted and edited research reports and regulatory documents in compliance with protocol and sponsor requirements, leveraging the knowledge of regulatory guidelines and extensive experience collaborating with study sponsors. 6- Ensured timely and accurate research information to sponsor satisfaction by implementing quality control processes, meeting deadlines, and validating and cleaning data.

01- Researched data processing operations and monitored proof of concept with new processes. 02- Set up, calibrated, and maintained laboratory and field research equipment for the requirements of the study. 03- Coded and verified data in accordance with the specified research protocol and coding procedures, entering data into a computer database for subsequent analysis. 04- Organized, labeled, and stored study biospecimens. 05- Conducted qualitative and quantitative analysis on assigned data. 06- Traveled to field sites to collect and record data and samples as appropriate to the study's specific objectives. 07- Created graphs, spreadsheets, and presentation slides to help researchers present findings. 08- Developed and maintained spreadsheets, questionnaires, and research tools. 09- Conducted surveys, interviews, and experimental research to facilitate data analysis. 10- Outlined key research in documents, spreadsheets, and reports. 11- Identified and resolved data issues to drive accuracy and integrity.