Posted:1 day ago|
Platform:
Work from Office
Full Time
The Database and Edit Check UAT Tester role is responsible for performing database UAT testing, maintaining database testing documentation, developing edit check test specifications, and conducting UAT for edit checks. This role requires close attention to detail and collaboration with other groups to ensure the accuracy and efficiency of our data management databases and edit checks. Roles & Responsibilities: Perform database testing to ensure the integrity and accuracy of data. Maintain comprehensive database testing documentation. Develop detailed edit check test specifications. Conduct UAT for edit checks to ensure they meet the required standards. Communicate and call out day-to-day issues and risks regarding the area of work. Assist with preparation for inspections and provide responses to questions and findings from regulatory authorities and other audits. Participate in data management and cross-functional working groups, including global network representation. Promote and advocate for data management standard methodologies internally and externally. Basic Qualifications & Experience: Masters degree and 3 to 4 years of life science, computer science, business administration or related discipline or equivalent experience OR Bachelors degree and 5 to 6 years of [life science, computer science, business administration or related discipline or equivalent experience OR Diploma and 9 to 10 years of [Job Codes Discipline and/or Sub-Discipline] experience General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or clinical research organization (CRO) company) Preferred Qualifications Must-Have Skills: Proficiency in database testing and edit check UAT Familiarity with testing and validation plans Proficient in testing documentation standard methodologies Knowledge of Good Clinical Practice Understanding of clinical data management processes Good-to-Have Skills: Familiarity with electronic data capture (EDC) systems and data management plans (DMP). Familiarity in inspection readiness Familiarity of database audit trails Familiarity of Trial Master Files Soft Skills: Excellent communication and collaboration skills. Detail-oriented with strong analytical and problem-solving abilities. Ability to work independently and as part of a team.
Amgen Inc
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