Job
Description
ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. What you will do Let’s do this. Let’s change the world. In this vital role you will be 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. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master’s degree and 1 to 3 years of life science, computer science, business administration or related discipline or equivalent experience OR Bachelor’s degree and 3 to 5 years of life science, computer science, business administration or related discipline or equivalent experience OR Diploma and 7 to 9 years of life science, computer science, business administration or related discipline or equivalent 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. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
