Quality Validation Analyst, Plymouth Meeting, PA
The Validation Analyst is responsible for understanding software validation in a government regulated environment with special attention to the Software Development Lifecycle (SDLC) validation processes which meet regulatory requirements.
The Validation Analyst ensures that all study work is conducted to CRF-Bracket’s procedures and processes and supports the CRF-Bracket Validation Methodologies. The goal of the Validation Analyst is to foster and promote quality throughout the SDLC/PLC.
The position requires a high level of integrity as this person is working on a client’s project and preparing documents that may be submitted to regulatory agencies (FDA, EMEA etc.) as needed, and actions impact the quality and reliability of the client's’ product.
Competencies and Personal Attributes
About CRF Health
Global Leader in eCOA Solutions
CRF Health is a global leader in eCOA (electronic Clinical Outcome Assessments) solutions for the life sciences industry. eCOA encompasses PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes) and ClinROs (Clinician or Rater Reported Outcomes) with outstanding project management focused on delivering value for our customers. Committed to driving the change to higher quality outcomes and more efficient paper-free clinical trials through improved patient engagement, our intuitive and patient-focused eCOA technology helps companies bring new medicines to market quickly, safely and more cost-effectively. Our complete eCOA solutions are ideal for home and site-based phase I-IV clinical trials across the world for many therapeutic areas and patient populations. More information can be found on our website.