Specialist IS Engineer

Lets do this. Lets change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Veeva Clinical Vault experience who has hands-on knowledge of Veeva Clinical Data Management System (CDMS), and involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime.

• Drive technical discussion related to the Veeva Vault technologies related to clinical Research & Development (R&D) applications.
• Drive database development activities per implementation project plan by working with various members of the Clinical Research Organization (CRO), and other external vendor teams.
• Collaborate with clinical data providers (Central Laboratories, Electronic Clinical Outcome Assessments (eCOA), Interactive Response Technology (IRT), etc.) to receive data and configure transfers based on requirements.
• Configure forms, rules, and other study items with Veeva Vault CDMS product during development and develop custom listings based on customer data cleaning requirements using SQL-based language.
• Conduct user acceptance testing with the customer, including coordination of all feedback, resolution of issues, and acceptance of the study .
• Support requirements gathering and specification creation process for all study integrations and release activities to ensure a smooth transition of the study to the customer.
• Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements.
• Participate and contribute to process product or standard methodologies initiatives and support developers and testers during the project lifecycle.
• Participate in Vault CDMS Product team discussions to convey data management activities, challenges, and end-user expectations.
• Configure and support data ingestions (imports) into Veeva Clinical Database (CDB).
• Define, author, and present various architecture footprints i.e. Business, Logical, Integration, Security, Infrastructure, etc.
• Define integration design by engaging Veeva technical team.
• Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations.
• Identify and resolve technical challenges effectively .
• Identify and resolve software bugs and performance issues.
• Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time.

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate Degree OR
• Masters degree with 4 - 6 years of experience in Computer Science, IT or related field OR
• Bachelors 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:

• Working knowledge of clinical trial processes specifically as they relate to data collection and review.
• Prior experience in programming languages such as (SAS, R, JSON, Python, SQL) with the ability to learn new programming languages (SQL based language).
• Experience in Clinical teams with a focus on data management, database building, or programming (e.g., SQL, C++, JavaScript, XML).
• End-user and/or Administrator experience with Clinical Data Capture software.
• Understanding of SaaS/Cloud solutions and technology.
• Experience working with system integrators for IRT, medical coding, eSource, Clinial Trial Management Systems (CTMS), Electronic Trial Master File (eTMF), and other clinical technologies.

• Solid understanding of cloud platforms (e.g., AWS, GCP, Azure) and containerization technologies (e.g., Docker, Kubernetes).
• Experience with monitoring and logging tools (e.g., Prometheus, Grafana, Splunk).
• Experience with data processing tools like Hadoop, Spark, or similar.
• Experience with SAP integration technologies.
• Relevant certifications such as CISSP, CompTIA Network+, or MCSE (preferred)

• 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.

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, well 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.

Objects in your future are closer than they appear. Join us.

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.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.