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Clinical Outcomes Assessment (COA) Manager

Tech Observer in Berkeley Heights, NJ, USA

Berkeley Heights, NJ or Basking Ridge, NJ
Bachelor's degree
Up to 25% travel
· Clinical Outcomes Assessment (COA) Manager is accountable for electronic COA (eCOA) in individual clinical research studies from study start up to close out working with the study team.
· 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
· Excellent interpersonal & leadership skills
· Uses a data driven approach to planning, executing, and problem solving
· Oversees eCOA vendor performance at the clinical trial level, including oversight of KPI, performing root cause analysis and identifying corrective actions, and serving as point of escalation for eCOA issues
· Trains new staff
· Must have excellent project management and communication skills.

Posted date: 10 days ago

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