Description
SUMMARY OF QUALIFICATIONS: My experience includes working for PAREXEL International for over seven years, following two years in pediatric neurological clinical research of Boston Children's Hospital. My recent experience includes Software Validation and assisting in project management as well as being directly trained on ClinPhone 4 at the PAREXEL office in Crawley, UK. My accomplishments in the role of Principal Software Validation Engineer included identifying the use of an existing Windows application for use on the test environment and successfully completed qualification testing. This resulted in a reduction of validation timelines by 10% at no cost to PAREXEL or to clients. I was a Subject-matter expert for the ClinPhone IxRS software in a variety of validation areas including ePRO (Electronic Patient Reported Outcomes) and client-facing bespoke web reporting. I managed an international team of Software Testers, ensuring timelines, Standard Operating Procedures, Good Data Recording Practices, client and study requirements were adhered to throughout the software development life cycle.
Accomplishments
Highlights:
Keywords
- Services
- Software
- Management
- Software Development
- Clinical Research
- Critical Care - Neurology
- Magnetic Resonance Imaging (MRI)
- Microsoft Windows
- MRI
- Neurology
- IRT
- IxRS
- randomization
- trial supply management
- testing
- process improvement
- SME
- ePRO
- validation
- quality assurance
- study management
- trial management
- software development lifecycle
- patient management
- subject management
- subject
- trial
- clinical
- phase
- gcp
- protocol
- pharmaceutical