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