Principal Data Engineer/Non-Line Manager/Experimental Medicine Japan D&A (Shinagawa, Japan, Tokyo)

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

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