- Study Builders develop electronic systems for clinical data capture and management, focusing on eCRF creation, edit check and business logic required to complete the study.
MAIN ACCOUNTABILITIES
Develop electronic clinical data management (eCDM) systems (eCRFs, edit checks, visit structures, system settings, role assignments, etc.)
Review specifications to assure the requirements are clear and appropriate.
May focus on either eCRF development or Rules (edit check) development or both.
Understand, and apply Client standards library to each study build.
Perform peer review of studies built by team members and complete necessary documentation.
Conduct change and proper version control process for requested and approved changes to production studies.
Track personal activities and time allocations to deliverable timelines to assure timeliness or escalation of problematic timelines.
Provide accurate daily/ weekly status reports to leadership.
Maintain issues logs and seek issue resolutions to assure delivery on time.
Attend and participate in eCDM team meetings
May mentor new study builders in their new roles, assist with questions, provide guidance for successful delivery.
Comply with eCDM team and company policies
Increase depth of knowledge of the clinical trials process and industry and technical eCDM expertise.
Maintain appropriate documentation as required by SOPs.
Perform all tasks as required by SOPs.
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