Quick Overview
Seniority
Mid Senior
Work mode
Hybrid
Location
Foster City, CA, United States
Posted
Yesterday
Agile
Job Description
We are seeking an experienced Clinical Repository Business Analyst / Consultant for evaluating external country-information repository solutions against ROCK requirements. The role will lead requirements analysis, vendor capability assessment, POC/UAT coordination, financial/TCO analysis, stakeholder alignment, and development of the final vendor recommendation and transition roadmap.
Skills / Experience
- Clinical Trial / Clinical Supply Chain Processes, Regulatory Content Management
- Repository / Knowledge Management Platforms; Data Governance & Information Management
- Experienced in regulated environments within life sciences or biopharmaceutical or related industry
- Agile / Project Management, Risk & Dependency Management, Change Management
- Integration & API Concepts, Security, Auditability & Validation Concepts
- PowerPoint / Excel / Visio or equivalent Analytical Tools+C7
- Bachelor Degree in Business Administration, Information Systems, Life Sciences, or related field
Job Description & Expected Outcome
- Compliance-driven and deadline-sensitive environment requiring strong coordination and execution skills
- Cross-functional collaboration with Systems, IT, Legal, Compliance, Testing, PM, and Business teams
- Requires structured tracking, documentation, prioritization, and audit readiness across multiple initiatives
- Complete comprehensive assessment of Freyr and Clarivate against ROCK requirements
- Establish vendor scorecard, evaluation criteria, POC scenarios, and acceptance thresholds
- Deliver executive recommendation, implementation roadmap, and ROCK transition plan
- Complete stakeholder requirement validation and requirements traceability matrix
- Coordinate POC/UAT activities and document findings, gaps, and risks
- Develop TCO, scaling, and build-vs-buy financial models
- Provide vendor recommendation and go/no-go decision support
- Ability to quickly adjust to new technologies, workflows, and environments
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