Allison Soriano Email & Phone Number

- Create technical specifications, manage, and implement over 25 EDC databases across a wide range of indications.- Design and build electronic Case Report Forms (eCRFs) based on the study protocol.-- Create eCRF workflows with a focus on user experience to ensure intuitive and high-quality data entry.-- Incorporate edit checks into eCRF designs to minimize flawed data entry and reduce burden of data reconciliations.-- Use CDISC and CDASH standards to facilitate data submissions to regulatory agencies.-Provide customers with guidance and domain expertise in study design and implementation.-Work with developers to ensure a quality and timely delivery of the study database.-Provide scope and effort estimates to customers for new and amended studies.-Design protocol amendment implementations in a way that minimizes the impact to existing data and maximizes quality of regulatory submissions.

Marietta, Ga

- Manage setup of over 50 clinical trial lab databases across many countries and regions, receiving numerous 100% customer satisfaction scores.- Wide-ranging clinical trial experience:-- Experience with several Top 20 pharmaceutical and biotech companies.-- Many indications, with specialty in autoimmune and cardiovascular diseases, neurology, and oncology.- Meticulously review and interpret clinical trial protocols to extract relevant information.- Provide scientific and technical support to clients, ensuring quality delivery within the project’s timelines throughout the lifecycle of the clinical trial.- Lead global teams to promote collaborative and harmonized setup of trials across more than 40 countries.- Design and continuously refine customer-level design standards to streamline project setup and facilitate repeatedly high-quality implementations.- Simultaneously launched multiple databases for a program of mega-trials on time.- Create departmental SOPs to improve quality, resulting in 5% reduction in QC findings.- Successfully managed the setup of multiple high profile studies in 50% less time with no compromise in quality.

Marietta,Ga

- Input data into project databases adhering to design specifications.- Perform a database configuration review and assist with validation of database specifications.- Global Subject Matter Expert on internal database building systems and processes.- Consult with IT as business representative in designing and implementing enhancements to clinical systems.-Research problems, gather information, and liaise with lab colleagues to help ensure projects are set-up in line with established procedures and customer requirements.-Update and maintain internal databases with generic project information and input project specific information, as directed.-Maintain project documentation files that provide project status and escalation.-Keep Project Managers and other relevant staff informed of any issues that may affect the smooth running of the project.- Develop solutions for routine project related issues and problems, within a limited scope.-Participate in local and global improvement projects as defined by the relevant process improvement management team.

Marietta, Ga

Atlanta, Georgia