Functional BA

Spectraforce
Foster City, CA, United States
14 days ago

Role details

Contract type
Temporary to permanent
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Job source

Tech stack

Microsoft Excel Application Programming Interfaces (APIs) Data Analysis Confluence JIRA Microsoft Azure Business Process Model and Notation Clinical Trial Management Systems Communications Protocols Data Governance Electronic Data Interchange (EDI) Middleware
+11 more
Microsoft Visio Oracle (Applications) Power BI Lucidchart Requirements Management SAP APO SQL Databases Tableau (Software) Expertise in Kinaxis Data Management GXP

Job 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.

  • 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 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.

Requirements

  • Hands-on experience with clinical supply planning tools such as Signant SmartSupply, 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, Lucidchart 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

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