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Clinical Outcomes Assessment (eCOA) Specialist

Tech Observer in Berkeley Heights, NJ, USA

· Responsible for eCOA project timelines, translations, eCOA study specifications, executing UAT, and ensuring collection of eCOA is in accordance with Standard Operating Procedures (SOPs) and ICH/GCP.

· Provides input into protocol development as it relates to clinical outcomes

· Responsible for reviewing and approving project related eCOA study documentation during the course of the Project Lifecycle

· Supports internally sourced studies and studies outsourced to Clinical Research Organizations (CROs)

· Responsible for creating and enforcing eCOA systems standards, managing vendor performance, and supporting training & education of stakeholders.

· Defines and supports strategy for eCOA migration and COA validation

· Demonstrated knowledge of eCOA system development processes

Posted date: 7 days ago

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