Specialist Business Analyst

This role involves working closely with clinical study start-up business collaborators, Veeva engineers, data engineers, AI/ML engineers to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems.

You will analyze business requirements and design information systems solutions. You will collaborate with multi-functional teams to understand business needs, identify system enhancements, and drive system implementation projects. Your solid experience in business analysis, system design, and project management will enable you to deliver innovative and effective technology products. You will collaborate with Product owners and developers to maintain an efficient and consistent process, ensuring quality work from the team.

• Collaborate with System Architects and Product Owners to manage business analysis activities for clinical study startup systems, ensuring alignment with engineering and product goals
• Capture the voice of the customer to define business processes and product needs
• Collaborate with Study startup business collaborators, Amgen Engineering teams and Veeva consultants to prioritize release scopes and refine the Product backlog
• Support the implementation and integrations of Veeva Study Startup tool with other Amgen systems
• Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs
• Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team
• Clearly express features in User Stories/requirements so all team members and collaborators understand how they fit into the product backlog
• Ensure Acceptance Criteria and Definition of Done are well-defined
• Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators
• Develop and complete effective product demonstrations for internal and external collaborators
• Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements
• Identify and manage risks associated with the systems, requirement validation, and user acceptance
• Develop & maintain documentations of configurations, processes, changes, communication plans and training plans for end users
• Ensure operational excellence, cybersecurity, and compliance.
• Collaborate with geographically dispersed teams, including those in the US and other international locations.
• Develop a culture of collaboration, innovation, and continuous improvement

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:

• Masters degree with 4 - 6 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR
• Bachelors degree with 6 - 8 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR
• Diploma with 10 - 12 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies
• Experience with Agile software development methodologies (Scrum)
• Excellent communication skills and the ability to interface with senior leadership with confidence and clarity
• Strong knowledge of clinical trial processes especially study startup process
• Hands-on experience with Veeva Clinical ecosystem
• Familiarity with regulatory requirements for Clinical Trials (e.g. 21 CFR Part11, ICH )
• Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA

• Experience in managing product features for PI planning and developing product roadmaps and user journeys
• Experience maintaining SaaS (software as a system) solutions and COTS (Commercial off the shelf) solutions
• Able to communicate technical or complex subject matters in business terms
• Jira Align experience
• Experience with data analysis, data modeling, and data visualization solutions such as Tableau and Spotfire
• Hands on experience writing SQL using any RDBMS (Redshift, Postgres, MySQL, Teradata, Oracle, etc.)
• Experience with AWS Services (like EC2, S3), Salesforce, Jira, and API gateway, etc.

• SAFe for Teams certification (preferred)
• Certifications in Veeva products (Preferred)
• Certified Business Analysis Professional (Preferred)

• Able to work under minimal direction
• Skilled in mentoring and delegation
• Excellent analytical and gap/fit assessment skills
• Strong verbal and written communication skills
• Ability to work effectively with global teams
• High degree of initiative and self-motivation
• Ability to handle multiple priorities successfully
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills