Principal Data Engineer/Non-Line Manager/Experimental Medicine Japan D&A

Basic Purpose of the Job Key contact partner in cultivating the "power of data" through: Data collection/curation, data review and data delivery Data standardization Process definition, testing and training Responsibilities include: Translating scientific requirements into technical specifications Collecting, ingesting, structuring, curating and standardizing clinical trial data Ensuring data quality and integrity through plausibility checks, anomaly detection and fraud detection methods Supporting clinical research development through advanced expertise in data engineering activities The role interprets scientific and clinical requirements and translates them into Therapeutic Area (TA) and Project-level technical specifications for new substances, indications and marketing claims. Key Accountabilities 1.

Strategic Data Engineering Leadership Responsible for: Translating requirements into project and Therapeutic Area-level technical specifications Providing project/TA-level clinical data to business stakeholders Gathering business requirements Developing global solutions for immediate and long-term business needs Managing clinical data environments at project and TA levels Resolving project and TA issues Success Measures Quality project/TA deliverables Timeline adherence Feedback from ExpMED colleagues, Product Owners and capability managers 2. Vendor, CRO & Outsourcing Oversight Responsible for: Leading and overseeing all Clinical Data Engineering work performed by external partners Managing CRO capacity planning Overseeing outsourced project and trial budgets Ensuring external deliverables meet quality standards Success Measures Quality oversight deliverables Timeline adherence Stakeholder feedback 3.

Data Quality, Integrity & Inspection Readiness Responsibilities include: Developing and testing new ways to improve data reliability, integrity and quality Ensuring real-time inspection readiness Supporting regulatory inspections and internal audits Maintaining compliance across all data-related activities Success Measures Quality mindset Process improvement contributions Audit and inspection readiness Feedback from Product Owners, Quality Management and capability leaders 4. Strategic Collaboration & Influence Collaborate with and influence cross-functional teams Partner with stakeholders inside and outside ExpMED Support project and product-level goals Promote team-based and cross-functional thinking Success Measures Collaboration effectiveness Stakeholder satisfaction Influence across functions 5.

Innovation & Future Data Solutions Stay current on advances in data science Evaluate new technologies and digital solutions Explore innovative approaches to: Data collection Data curation Data standardization Digital technologies Process optimization Convert insights into new Clinical Data Engineering approaches that support: Clinical development Regulatory submissions Product commercialization Success Measures Innovation quality Regulatory acceptance Team and chapter feedback 6. Training & Capability Development Deliver and support Clinical Data Engineering training Promote best practices Increase knowledge sharing across the CDE Community of Practice Success Measures Training effectiveness Participant satisfaction Increased organizational capability 7.

Process Development & External Representation Participate in or lead cross-functional BI process improvement initiatives Drive strategic CDE-related improvements Participate in external working groups and industry forums Success Measures Leadership effectiveness Business impact of process improvements Feedback from Global Product Owners and Product Owners Regulatory & Organizational Requirements Must understand and implement: Regulatory Requirements International Good Clinical Practice standards International Good Statistical Practice standards ICH guidelines including: ICH E3 ICH E5 ICH E6 ICH E8 ICH E9 ICH E10 ICH E17 Organizational Requirements Clinical development guidelines Data standardization guidance BI processes and SOPs Clinical Development Plan-related requirements All work must be conducted: With the highest ethical standards In compliance with BI values In accordance with quality requirements Job Complexity Solves complex and defined problems Has strategic impact within the Clinical Data Engineering function Balances requirements across multiple departments and business units Influences broader organizational decision-making Interfaces Collaborates with internal and external stakeholders including: Medicine Therapeutic Areas TMCP GRA ExpMED functions Represents BI on: Critical regulatory issues Data collection strategies Data review and delivery Data standardization Process definition Testing and training at the project and asset levels. Job Expertise Required: Clinical Development Expertise Broad knowledge of clinical trial development Advanced understanding of global clinical development processes Demonstrated ability to: Build data solutions Test systems Curate data Oversee data operations Interpret clinical trial data Innovation & Problem Solving Strong curiosity and creativity in solving: Data collection challenges Data curation challenges Standardization issues Process and training challenges Experience Many (≥ 6 years) of professional experience Pharmaceutical industry, CRO or academic research experience Leadership experience required Job Impact Responsible for: Data collection and curation Data review and delivery Data standardization Process definition Testing and training for global clinical trials across products in development and post-approval phases.

Additionally responsible for: Leading internal and external CDE resources Managing CRO activities Overseeing outsourced project and trial budgets Delivering strategic outcomes across clinical development programs Education Requirements Bachelor's Degree or Master's Degree Preferred fields: Life Sciences Computer Science Software Engineering Computer Engineering Related disciplines Required Capabilities Technical Expertise Deep expertise with: Electronic Data Capture (EDC) systems Data Collection Tools Data Review Tools Data Standardization methodologies Clinical Knowledge Strong clinical trial design knowledge Understanding of medical terminology Extensive experience working with clinical trial information Leadership & Management Leadership experience Vendor management expertise Training and coaching capability Meeting facilitation skills Communication Strong communication skills Persuasive and influential communication style Ability to explain complex concepts clearly Business & Project Skills Organizational skills Problem-solving ability Negotiation skills Time management Initiative and ownership Collaboration Ability to lead multidisciplinary teams Build strong vendor relationships Collaborate globally across cultures Training Ability to develop and deliver technical training programs Language English: Fluent (Read / Write / Speak) Quick Candidate Snapshot Ideal profile: 6+ years in Clinical Data Management / Clinical Data Engineering Significant experience with EDC systems and clinical trial data ecosystems Strong understanding of GCP, ICH guidelines and clinical development Experience managing vendors and CROs Proven leadership capability Experience driving strategic process improvements Ability to influence cross-functional stakeholders Bachelor's or Master's degree in Life Sciences, Computer Science, Engineering or related field Fluent English communication skills