Functional Business Analyst - Clinical

Job Description: Functional Business Analyst

hybrid role must 

Location – Foster City, CA

Role Overview: We are seeking an experienced Functional Business Analyst with strong clinical supply chain planning and CDOP (Clinical Development Operations Plan) process experience. The role will support business process definition, requirements gathering, documentation, data readiness, testing, and user enablement for clinical supply planning initiatives. The ideal candidate will have the ability to work closely with business, IT, technical architecture, data, testing, and vendor teams to translate clinical supply chain requirements into clear user stories, process flows, data templates, test scripts, and training materials.

Key Responsibilities

·         Technical Architecture Support: Support technical architecture discussions by documenting business process impacts, planning assumptions, system touchpoints, data requirements, integration dependencies, and functional considerations for clinical supply chain planning solutions.

·         Requirement Gathering and Documentation: Collaborate with business users, clinical operations, supply planning, IT, technical architecture, data, and vendor teams to capture, validate, and document functional requirements, business rules, process needs, and data requirements.

·         User Story Development: Convert business and CDOP process requirements into well-defined user stories, acceptance criteria, process scenarios, and backlog items to support Agile delivery.

·         Process Flow Documentation: Create current-state and future-state process flows covering clinical supply planning, CDOP activities, study setup, demand planning, supply planning, master data maintenance, testing, and operational handoffs.

·         Master Data Requirements: Define master data requirements for study master data, supply planning attributes, product, protocol, country, site, depot, packaging, inventory, demand, supply, and other planning-related data elements.

·         Study Master Data Requirements: Analyze and document study master data requirements, required fields, ownership, source systems, data dependencies, validation rules, business rules, and ongoing maintenance processes.

·         Data Template Creation: Develop and maintain data templates for study master data, supply planning attributes, planning parameters, data loads, validation checks, and migration readiness.

·         Data Cleansing: Support data profiling, cleansing, standardization, enrichment, duplicate resolution, gap analysis, and quality checks to ensure data readiness for testing, migration, and business adoption.

·         Data Migration Support: Coordinate data mapping, transformation rules, migration trackers, load validation, reconciliation, defect resolution, and cutover readiness for study and supply planning data migration.

·         Test Script Preparation: Prepare SIT test cases, UAT scripts, regression scenarios, and end-to-end planning process test scripts aligned to clinical supply chain planning and CDOP business requirements.

·         SIT Support: Support system integration testing by preparing test scenarios, coordinating test execution, validating outcomes, documenting defects, tracking issue resolution, and ensuring requirements traceability.

·         UAT Support: Assist business users during UAT by preparing test packs, facilitating test execution, clarifying requirements, triaging defects, documenting outcomes, and supporting sign-off activities.

·         Training Documentation: Develop training documents, job aids, quick reference guides, process instructions, data entry guides, and user support materials to enable effective adoption of clinical supply planning processes.

·         Stakeholder Coordination: Act as a liaison between business, IT, architecture, data, testing, vendor, and clinical supply planning teams to ensure clear communication, timely decisions, and successful delivery.

Required Skills and Experience

·         Strong experience as a Functional Business Analyst, Business Analyst, Business Systems Analyst, or Product Analyst supporting enterprise business process and technology implementation programs.

·         Hands-on experience in clinical supply chain planning, clinical trial supply planning, study planning, demand planning, supply planning, and CDOP process activities.

·         Strong understanding of clinical study master data, supply planning attributes, planning parameters, study setup, supply network, inventory, demand, supply, packaging, depot, site, and country-level planning data.

·         Experience documenting requirements, user stories, acceptance criteria, process flows, data requirements, business rules, test scripts, and training materials.

·         Experience creating and maintaining data templates for study master data, supply planning attributes, planning parameters, data loads, validation, and migration readiness.

·         Experience supporting data cleansing, data validation, source-to-target mapping, data migration, reconciliation, issue resolution, and cutover readiness activities.

·         Experience preparing and executing SIT test cases, UAT scripts, regression scenarios, and end-to-end clinical supply planning process test scripts.

·         Ability to work with technical architecture teams to capture business process impacts, integration dependencies, functional considerations, and planning data requirements.

·         Strong communication, facilitation, analytical thinking, stakeholder management, documentation, and problem-solving skills.

·         Experience using tools such as Jira, Azure DevOps, Confluence, Visio, Lucidchart, Excel, SharePoint, Smartsheet, ServiceNow, or similar delivery and documentation platforms.

·         Ability to manage multiple priorities, drive follow-ups, support cross-functional workshops, and collaborate effectively across business, IT, vendor, and testing teams.

Preferred Qualifications

·         Bachelor’s degree or higher in Life Sciences, Supply Chain Management, Business Administration, Information Technology, Engineering, or a related field.

·         Prior experience supporting pharmaceutical, biotechnology, CRO, clinical trial operations, clinical supply chain, or regulated life sciences programs is highly desirable.

·         Experience with planning platforms or clinical supply systems used for demand planning, supply planning, study planning, inventory planning, or supply chain operations is preferred.

·         Experience supporting Agile delivery, backlog grooming, sprint planning, requirements traceability, release readiness, go-live, and hypercare activities is preferred.

·         Certification in Business Analysis, Agile, Scrum, Supply Chain, APICS/ASCM, or a related discipline is preferred but not required.