Roles & Responsibilities
- Participate in technical discussions related to the Veeva Vault within Clinical Trial Management, Monitoring, and Engagement (CTMME) product team.
- Drive development and maintenance activities per the release calendar by working with various product team members and business partners.
- Conduct user acceptance testing (UAT) with the customer, including coordination of feedback, issue resolution, and acceptance of the study.
- Support requirements gathering and specification creation for development and maintenance work.
- Communicate potential risks and contingency plans with project management to ensure compliance with regulatory and Amgen procedural requirements.
- Participate in and contribute to process, product, or best practice initiatives; support developers and testers during the project lifecycle.
- Define, author, and present various architecture footprints such as Business, Logical, Integration, Security, and Infrastructure.
- Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations.
- Develop and implement unit tests, integration tests, and other testing strategies to ensure software quality, following IS change control and GxP validation processes.
- Identify and resolve technical challenges, bugs, and maintenance requests effectively.
- Work closely with cross-functional teams including product management, design, and QA to deliver high-quality software on time.
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 Computer Science, IT, or related field experience
- OR
- Bachelor's degree and 3 to 5 years of Computer Science, IT, or related field experience
- OR
- Diploma and 7 to 9 years of Computer Science, IT, or related field experience
Functional Skills
Must-Have Skills
- Proficiency in Veeva Vault configuration and customization
- Proficiency in programming languages such as Python or JavaScript
- Experience with API integrations (e.g., MuleSoft)
- Strong understanding of software development methodologies (Agile/Scrum)
- Experience with version control systems (e.g., Git)
- Proficiency in writing SQL queries
- Working knowledge of clinical trial processes, especially software validation
- Strong problem-solving skills for debugging and adapting to change
- Excellent communication skills for explaining design decisions and team collaboration
Good-to-Have Skills
- Familiarity with relational databases (e.g., MySQL, SQL Server, PostgreSQL)
- Strong written and verbal communication skills; ability to explain technical concepts to non-technical clients
- High learning agility, analytical thinking, and problem-solving capabilities
- Experience in implementing GxP-compliant projects
- In-depth expertise in SDLC: requirements, design, testing, data analysis, and change control
Professional Certifications
- SAFe for Teams certification (Preferred)
Soft Skills
- Excellent analytical and troubleshooting abilities
- 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
