eCOA Manager

The eCOA Manager is responsible for driving all eCOA-related deliverables and overseeing all day-to-day eCOA activities within Study Start-Up and any change management support. They establish requirements for eCOA solutions, create and maintain eCOA specifications, and assist in the design and development of Case Report Forms for eCOA data collection. They define and assist in testing Edit Checks and/or Notifications related to eCOA solutions and create test cases for database validation. The manager also validates study calculations derived from ePRO per Protocol requirements, supports CDISC-compliant mapping of eCOA data, and defines and establishes eCOA reporting needs. They create study training materials for use of eCOA solutions, review eCOA-related information within study plans, and perform database validation for eCOA solutions. They will also contribute to the continuous improvement of CDM and the wider organization through information sharing, training, and education.