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