Functional BA

Job Title: Functional Business Analyst Clinical Demand & Supply Planning

Location: Hybrid Foster City, CA

Tax Term (W2, C2C): W2

Job Type (Permanent/Contract): Contract

Duration: Long Term

Description:
Experienced Business Analyst / Functional Consultant for a Clinical Demand and Supply Planning project. 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.

Role and Responsibilities:

• 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 SmartSupply, 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 a GxP / 21 CFR Part 11 environment.
• Support stakeholder management, change management, training and user adoption.

• Required Skills:

• Business Analyst
• Clinical Demand & Supply Planning
• Clinical Supply Chain
• Clinical Trial Management
• Signant SmartSupply
• SAP IBP
• Kinaxis
• Oracle
• 4C
• Jira
• Azure DevOps
• Confluence
• Visio
• Lucidchart
• BPMN
• Excel
• SQL
• Power BI
• Tableau
• APIs
• EDI
• Middleware Integrations
• Master Data Management
• Clinical Trial Operations
• Protocol Design
• Patient Enrollment
• Randomization
• IP Supply Chain
• GCP
• GMP
• 21 CFR Part 11
• Annex 11

• Qualifications:

• 13+ years of Business Analysis experience.
• Pharmaceutical/biotech industry experience with Clinical Supply Chain, Clinical Demand & Supply Planning, or Clinical Trial Management projects.
• Hands-on experience with clinical supply planning tools such as Signant SmartSupply, 4C, SAP IBP, Kinaxis, or equivalent.
• Experience working in a GxP-regulated environment.
• Strong requirements management using Jira, Azure DevOps, or Confluence.
• Process modeling experience using Visio, Lucidchart, or BPMN tools.
• Data analysis experience using Excel, SQL, Power BI, or Tableau.
• Working understanding of APIs, EDI, middleware integrations, and master data management.
• Strong 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.
• Excellent analytical, problem-solving, communication, stakeholder management, and cross-functional collaboration skills.