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

NBI(Nippon Boehringer Ingelheim Co., Ltd.) -
品川区大崎

今すぐ応募する

求人の詳細

5時間前

資格とスキル

修士号
大卒
コミュニケーションスキル

仕事内容の詳細

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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electronic engineerの新着求人をメールで受け取る

Basic Purpose of the Job

Key Accountabilities

1. Strategic Data Engineering Leadership

Success Measures

2. Vendor, CRO & Outsourcing Oversight

Success Measures

3. Data Quality, Integrity & Inspection Readiness

Success Measures

4. Strategic Collaboration & Influence

Success Measures

5. Innovation & Future Data Solutions

Success Measures

6. Training & Capability Development

Success Measures

7. Process Development & External Representation

Success Measures

Regulatory & Organizational Requirements

Regulatory Requirements

Organizational Requirements

Job Complexity

Interfaces

Job Expertise

Clinical Development Expertise

Innovation & Problem Solving

Experience

Job Impact

Education Requirements

Required Capabilities

Technical Expertise

Clinical Knowledge

Leadership & Management

Communication

Business & Project Skills

Collaboration

Training

Language

Quick Candidate Snapshot