Conduct audits of (a) EWs internal clinical processes (b) clinical sites and (c) vendor audits with increased complexity and volume. Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of nonconformance findings. Evaluate the appropriateness and effectiveness of previous corrective actions, Develop and execute audit plans and schedules for compliance audits of assigned clinical study projects.
Manage external documents and web-based subscription services including standards, specifications and technical papers required by the business. Status and maintain current specifications and post change announcements as required. Procure and fulfill request for various industry standards and specifications as new documents are required.
Developing and writing responses to customers for product complaints. Take complex medical procedure information and determine the course of events related to each complaint and write investigation findings in response to customer inquiries.