Technical Analyst - UAT for Clinical Data Systems

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Ihre Aufgaben

• Develops study-level User Acceptance Test (UAT) Plan and identifies all UAT scenarios to be included in the UAT scripts as assigned.

• Develops study-level UAT Scripts for all Clinical Data Collection Systems (For ex: EDC, eCOA, eConsent, IRT, etc.) to ensure database is setup per protocol requirements.

• Supports pre-UAT kick off meeting and performs just in time training (as needed) to the testers on UAT execution/documentation.

• Supports UAT execution for the study team.

• Creates Issue Log from individual tester's UAT scripts

• Obtains signatures for all testers as appropriate, ensures all UAT documentation is completed and submitted to Agios Study DM Lead.

• Performs technical review of the EDC database to ensure database is setup per protocol requirements.

• Maintains high quality of deliverables with UAT/validation and resolution of issues following good documentation practices.

Ihr Profil

• B.S. (or equivalent degree) and 5+ years of relevant work experience

• 3+ yrs experience programming and building EDC databases.

• Good understanding of eCOA, IRT systems/data.

• Demonstrates in-depth understanding of regulatory, industry, and technology standards and requirements

• Demonstrates in-depth understanding of UAT/validation terminology, and protocol designs

• Displays good organizational skills, problem-solving abilities, time management skills and initiative Communicates effectively in verbal presentations and written technical reports to all stakeholders