Mgr Information Systems

Job Description

What you will do Let's do this. Let's change the world. In this vital role you will responsible for leading the testing activities for software applications and solutions that meet business needs and ensuring the availability of critical systems and applications. This role is for a lead tester and validation expert with functional and system knowledge for Clinical Data Management, Interactive Response Technology (IRT) solutions. The role involves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions. Roles & Responsibilities: Participate in requirement discussions related to the RBM / RBQM system(s) within Clinical Data Management and Interactive Response Technology (CDMIRT) product team, in order to create test scripts. Build test scripts per implementation project plan by working with various members of the product team and business partners. Conduct informal and formal testing, consolidate all the findings and coordinate with developer(s) and business partners to resolve all the issues. Perform regression testing to verify the changes do not negatively impact existing system functionality. Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements. Identify and resolve technical challenges/bugs effectively. Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time. Support the creating and implementation of automated testing frameworks to improve efficiency and consistency. 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: Doctorate Degree OR Master's degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelor's degree with 6 - 8 years of experience in Computer Science, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT or related field. Preferred Qualifications: Must-Have Skills: Knowledge of clinical trial processes specifically software validation processes. Experience with testing methodologies and automation practices. Experience with testing tools such as HP Application Lifecycle Management (ALM) and Veeva vault validation management. Experience in conducting testing activities in GxP systems. Good Problem-solving skills - Identifying and fixing bugs, adapting to changes. Good communication skills - Explaining design decisions, collaborating with teams. Experienced in Agile methodology. Good-to-Have Skills: Experience in Risk-based Approach to Change Management of Validated GxP Systems. Solid understanding of SQL scripting. Experience in RBM/RBQM systems. Experience with cloud-based technologies. Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFE for Teams certification (Preferred) Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills