Functional BA

Our Client, an IT Services and Consultant company, is looking for a Functional BA for their Foster City, CA/Hybrid location.
 
Responsibilities:

• The role partners with clinical supply, business and IT stakeholders to elicit requirements, map as-is/to-be processes, define planning workflows, KPIs, dashboards and validation needs, and support tool implementation across clinical demand forecasting, supply planning, inventory, manufacturing/packaging, depot/site distribution, returns, reconciliation and destruction.
• Elicit, analyze and document business, functional and non-functional requirements; convert business needs into user stories, use cases and acceptance criteria.
• Facilitate workshops, interviews and process discovery across clinical demand forecasting, supply planning, inventory management, manufacturing/packaging, depot/site distribution and returns/reconciliation/destruction.
• Support solution design for clinical supply planning platforms such as Signant Smart Supply, SAP IBP, Kinaxis, Oracle, 4C or equivalent; define business rules, workflows, alerts, integration points and reporting requirements.
• Define KPIs, dashboards and data requirements for protocol, forecast accuracy, inventory/stock-out risk, expiry, manufacturing/packaging adherence and depot/site distribution performance; support master data governance and data quality.
• Develop test scenarios, scripts and traceability matrices; coordinate SIT, UAT and CSV activities in GxP / 21 CFR Part 11 context; support stakeholder management, change management, training and adoption.
• Pharmaceutical / biotech industry experience with Clinical Supply Chain, Clinical Demand & Supply Planning or Clinical Trial Management project exposure.
• Hands-on experience with clinical supply planning tools such as Signant Smart Supply, 4C, SAP IBP, Kinaxis or equivalent; experience in a GxP-regulated environment.

• Strong requirements management using Jira, Azure DevOps or Confluence; process modeling using Visio, Lucid chart or BPMN tools.
• Data analysis using Excel, SQL, Power BI or Tableau; working understanding of APIs, EDI, middleware integrations and master data management.
• Strong domain understanding of clinical trial operations, protocol design, patient enrollment, randomization and IP supply chain; familiarity with GCP, GMP, 21 CFR Part 11 and Annex 11.
• Strong analytical problem-solving, communication, stakeholder management, executive presence, ambiguity management and global cross-functional collaboration skills
• Years of Experience: 13+ Years of Experience

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities