Sr Associate IS Analyst

Role Description:

The role demonstrates domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with Clinical Study Start-up (SSU) & Program Study Design Planning (PSDP) business collaborators, Salesforce engineers, data engineers, AI/ML engineers to analyze, support and resolve issues with SSU & PSDP data across integrated systems. You will collaborate with Product owners and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team.

Roles & Responsibilities:

• Monitor, solve and resolve issues related to SSU & PSDP data across multiple systems
• Conduct detailed investigations into system disruptions, data anomalies, or processing delays and implement corrective and preventive measures.
• Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues
• Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations.
• Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability.
• Collaborate on the development of test plans, scenarios to ensure robust validation of system updates, patches and new features
• Perform regression testing to verify the changes do not negatively impact existing system functionality
• Lead and facilitate meetings with collaborators and engineers to define project scope, clarify expectations, and gain vital technical information for development.
• Partner with engineers to assess the feasibility of new features and solutions. Understand technical constraints and dependencies to ensure that proposed solutions are viable.
• Collaborate with geographically dispersed teams, including those in the US and other international locations
• Foster a culture of collaboration, innovation, and continuous improvement

What we expect of you

Basic Qualifications and Experience:

• Master’s degree with 1 - 3 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR
• Bachelor’s degree with 3 - 5 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR
• Diploma with 7 - 9 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies

Functional Skills:

Must-Have Skills

• Demonstrated expertise in monitoring, fix, and resolving data and system issues.
• Experienced in database programming languages using SQL.
• Experience with Software development lifecycle (SDLC) & Agile software development methodologies (Scrum)
• Good communication skills
• Hands-on experience with the ITIL framework.
• 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

Good-to-Have Skills:

• Experience maintaining SaaS (software as a system) solutions and COTS (Commercial off the shelf) solutions
• Experience with data analysis, data modeling, and data visualization solutions such as Tableau and Spotfire
• Solid understanding of SQL using any RDBMS (Redshift, Postgres, MySQL, Teradata, Oracle, etc.)
• Experience with AWS Services (like EC2, S3), Salesforce, Jira, and API gateway, etc.
• Experienced in managing GxP systems and implementing GxP projects.
• Experience with Veeva Vault solutions is plus

Professional Certifications (please mention if the certification is preferred or mandatory for the role):

• SAFe for Teams certification (preferred)

Soft Skills:

• Able to work under minimal supervision
• Excellent analytical and gap/fit assessment skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation, with strong organizational skills
• Ability to manage multiple priorities successfully

Shift Information:

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.