Associate CDM Systems NB50300711- So. San Francisco, CA

Amgen (NASDAQ:AMGN), a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.The Associate role is focused on ensuring that outsourced electronic trial operation systems meet or exceed Amgen’s qualitative expectations. The individual in this role will use software test methods to write and execute functional, system and performance test plans and test cases. The individual will write test reports and maintain significant levels of test documentation as well as log and track errors. The Associate will ensure communication of project test status to project team members and will be responsible for the timely delivery of all test deliverables. Key Responsibilities include: • Implement a logical, risk-based test approach• Write clear, concise and thorough test documents• Execute test cases according to the defined test plans and guidelines• Perform peer review on project test documentation• Facilitate project testing activity with Internal and External clients• Coordinate project test efforts with multiple testers• Investigate, track and manage findings and escalate as appropriate• Assist in assessing timeline deliverables• Provide work status reports• Participate in project status meetings• Ensure the timely delivery of all client deliverables (internal and external)• Ensure full compliance to testing guidelines and qualitative testing procedures• Participate in ongoing process improvement, and recommend process change• Lead special projects as assigned• Adhere to all Amgen policies, clinical development processes, SOPs, and group guidelines• Bachelor’s Degree in life science, computer science, engineering or business • 1-3 years of experience in quality assurance, business analysis, clinical research or data management.• Ideal candidate will possess proficiency in converting complex technical and business requirements into an understandable test plan and test casesPreferred qualifications• Experience with clinical systems, such as CTMS, EDC, IVRS, Oracle Clinical in the pharmaceutical/biotechnology industry preferred• Candidates should demonstrate clinical and technical expertise, attention to detail, and excellent documentation and communication skills. • Knowledgeable in Good Clinical Practices, Software Development Lifecycle, and FDA regulations• Excellent time management and organization skills required• Must have sound problem resolution, judgment, and decision-making skills• Must be able to work well in a team-based environment with minimal supervision, and communicate effectively with clients, peers, and management.• Ability to prioritize client needs and manage multiple projects simultaneously Amgen is the leading human therapeutics company in the biotechnology industry. Our mission is to serve patients. We foster a culture of innovation, using our expertise in advanced science and technology to find new and better medicines to fight serious illness. For more information about Amgen, our visionary science, and our powerful medicines, visit: www.amgen.com Company: Amgen San Francisco LLC Location: South San Francisco, CA 94080 Job Category: Biotech/R&D/Science Reference Code: 50300711