Position Purpose

Leads the effective, efficient, and regulatory-compliant use of the data architecture in the clinical database management system for both clinical trials and PMS. Provides exceptional technical capabilities to Clinical Data Sciences (CDS) at Pfizer Japan and other partner lines to achieve Pfizer's strategic and operational goals. Ensures that the appropriate platform is maintained to support PMS project delivery with quality, consistency, and effectiveness.

Primary Role & Responsibility

• Designs, builds and updates data collection tools (including CRFs/Study DB), logical checks and extract views to align with protocols and meet study needs.
• Provides critical ideas and insights to significantly enhance business processes in clinical data management from a database management perspective.
• Oversees technical activities in Study Set Up conducted by external resources.
• Serves as the central point for the development and maintenance of data collection standards for PMS, as well as communication and training regarding them.
• Takes accountability for local system implementation and relevant services of EDCs used for PMS from a technical perspective. Identifies any system issues/problems and communicates them to management and vendors to ensure a regulatory-compliant, effective and user-friendly EDC solution.
• Supports global system implementation. Identifies and escalates any critical issues/problems to global counterparts to correct or mitigate risks.
• Provides technical advice to Japan study teams on Japan-specific matters.
• Leads technical activities such as responding to technical inquiries and amending study databases on legacy business technology still in operation.
• Works on behalf of the Clinical Data Sciences Group to develop the technical expertise of staff as appropriate.

• Bachelor's degree in biological sciences, computer science, or a related discipline
• At least 5 years (preferably 10 years) of experience in Clinical Database Programming
• Extensive experience translating study needs into CDISC standards and programming study databases accordingly
• Demonstrated experience implementing data integration between EDC and other systems, including Clinical Trial Management Systems and Safety Databases
• Deep insight into data standards management
• Demonstrated knowledge of Software Development Life Cycle and Computerized System Validation
• Demonstrated knowledge of clinical data management processes and principles
• A thorough understanding of the business process for data acquisition, aggregation and analysis for reporting of clinical trials
• Demonstrated knowledge of regulatory requirements (e.g., ICH guidelines, GCP, GPSP and related regulatory notifications)
• Demonstrated experiences in leading project management
• Basic knowledge of clinical statistics
• Biological and medical knowledge sufficient to discuss with the Study Team and propose optimal database designs
• Demonstrated competency in enhancing business processes
• Customer-focused mindset with a strong respect for teamwork
• Demonstrated effective verbal and written communication skills, with the ability to adapt communications to the audience
• Native-level proficiency in Japanese and business-level proficiency in English (TOEIC score of 730+ or equivalent)

• Master's degree in the above discipline
• Experience in activities with relevant pharmaceutical industry organizations
• Business analysis experience