◆Basic Purpose of the Job
Key contact partner in cultivating the "power of data" through:

1 Data collection/curation, data review and data delivery
2 Data standardization
3 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