ビジネスシステムアナリスト/ Business System Analyst

A foreign life science company is looking for a Business System Analyst. The chosen applicant will support the implementation and operation of RTSM applications by partnering closely with client services and internal teams.

Responsibilities:

• Partner closely with the Client Services Lead to support the implementation of client RTSM applications and enable client start-up targets
• Attend client meetings and design sessions, record meeting notes, suggest solutions to client challenges, and relay key information
• Log, track, and drive resolution of functional and technical issues identified during implementation and prior to go-live
• Ensure adherence to required deliverables and milestones in accordance with Project Management SOPs and work instructions
• Collaborate with the Client Services Lead to resolve functional and technical issues during implementation and pre–go-live phases
• Drive project-specific validation activities, including build verification testing, validation testing, system setup, and implementation
• Develop and execute testing scripts
• Develop client- and site-facing training materials during study implementation
• Support system integration activities as needed
• Develop and maintain study timelines using the Project Management Tracker and JIRA, ensuring alignment across internal teams
• Support development of study data management plans and internal support reference materials
• Act as an internal escalation point for Customer Support on system or support-related issues
• Participate in client audits as required

Requirements:

• Bachelor’s degree or equivalent in a life science, supply chain management, or information technology field
• More than 3 years of experience in the clinical research field (clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation is preferred)
• Software implementation and testing experience (clinical research or supply chain-related industry is preferred)
• Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11 are a plus
• Ability and willingness to travel
• Proficient in English or Mandarin

Preferred Requirements:

• More than 7 years of relevant system implementation experience in a related industry may be considered
• Clinical supplies forecasting and management experience
• Experience with IRT/RTSM and clinical supplies forecasting/simulation tools
• Experience working with agile development methodology
• Supply chain certification or experience
• Proficient in Japanese

About the Company:

A global life sciences technology company that provides software for clinical research. The company delivers fully cloud-based, highly configurable solutions that help pharmaceutical and biotech organisations optimise clinical trial operations, improve supply forecasting, and accelerate the delivery of investigational medicines to patients.

Keywords:

技術, 医療, ライフサイエンス, ソフトウェア, 外資系

Job Ref: Q54B6T