Senior Clinical Data Engineer/Staff/Experimental Medicine Japan D&A (Shinagawa, Japan, Tokyo)
About this opportunity
Basic Purpose of the Job
Key contact partner in cultivating the "power of data" by means of:
Data collection/curation, data review, data delivery
Data standardization
Process definition, testing and training
Translate scientific requirements into technical specifications. Collect, ingest, structure, curate and standardize clinical trial-related data from internal and external sources.
Ensure data quality and integrity by implementing plausibility checks, anomaly detection and fraud detection methods in data collection systems.
Support the clinical research development process through advanced expertise in:
Data collection/curation, data review and delivery
Data standardization
Process definition, testing and training
Interpret scientific and clinical requirements and translate them into project/trial-level technical specifications for new substances, indications and marketing claims.
Key Accountabilities
1. Technical Specifications and Data Delivery
Responsible for:
Interpreting requirements and translating them into trial/project-level technical specifications
Providing clinical trial/project data to business users
Facilitating requirements gathering
Developing solutions for immediate and long-term business needs
Monitoring and maintaining clinical data environments
Responding to trial/project issues
Success Measures
Quality trial/project deliverables
Timeline adherence
Feedback from development teams, Product Owners (POs) and capability managers
2. Vendor Oversight
Provide oversight of:
Data collection/curation
Data review and delivery
Data standardization
Process definition, testing and training
performed by BPOs/CROs.
Success Measures
Quality oversight deliverables
Timeline adherence
Feedback from stakeholders
3. Data Quality & Inspection Readiness
Recommend and test ways to improve data reliability, integrity and quality
Ensure real-time inspection readiness of all data collection and data review/delivery deliverables
Participate in regulatory inspections and internal audits
Success Measures
Quality mindset
Process improvement contributions
Inspection and audit readiness
Feedback from POs, capability managers and Quality Management partners
4. Cross-Functional Collaboration
Work closely with development teams within ExpMED and other BI functions
Contribute to cross-functional and team-based thinking
Success Measures
Feedback and satisfaction from collaboration partners
5. Innovation & Continuous Learning
Stay current with data science developments
Explore new data collection, curation, standardization and digital technologies
Promote innovative tools and processes
Success Measures
Quality and innovation of new solutions
Regulatory acceptability
Team and chapter feedback
6. Training & Knowledge Sharing
Conduct and support training for Clinical Data Engineers
Success Measures
Positive trainee feedback
Increased knowledge sharing within the CDE Community of Practice
7. Process Development
Participate in BI cross-functional process development teams
Drive and plan relevant Clinical Data Engineering activities
Success Measures
Quality and frequency of participation
Business impact of process improvements
Feedback from Global Product Owners and Product Owners
Regulatory and Organizational Requirements
Must know, understand and implement:
International regulations and guidelines for Good Clinical Practice and statistical practice
ICH guidelines including: ICH E3
ICH E5
ICH E6
ICH E8
ICH E9
ICH E10
ICH E17
Clinical development and data standardization guidelines
BI processes and SOPs governing clinical development
All work must be performed:
With high ethical and professional standards
According to BI values
In compliance with quality requirements
Job Complexity
Solves complex and defined problems
Primarily operational with limited strategic impact
Considers requirements and needs of other departments and functions
Interfaces
Interacts with functions and roles within and outside ExpMED, including:
Medicine
Therapeutic Areas
TMCP
GRA
Represents BI on regulatory matters relating to:
Data collection
Data review
Data delivery
Data standardization
Process definition
Testing
Training
at trial, project and asset levels.
Job Expertise
Required:
Advanced understanding of the clinical trial development process
Demonstrated experience building, testing, curating, overseeing and interpreting clinical trial data
Curiosity and innovation in solving data-related challenges
Pharmaceutical industry, CRO or academic research experience
At least 3 years of professional experience
Basic leadership experience
Job Impact
Responsible for global clinical trial deliverables involving:
Data collection/curation
Data review and delivery
Data standardization
Process definition
Testing
Training
for products in clinical development and post-approval phases.
Independently oversees related activities performed by BPOs and CROs.
Education Requirements
Bachelor's Degree (or equivalent combination of qualifications and experience)
Preferred fields:
Life Sciences
Computer Science
Software Engineering
Computer Engineering
Related disciplines
Master's Degree preferred (e.g., MBA, MSc)
Required Capabilities
Technical
Knowledge of Data Collection Tools (EDC systems)
Knowledge of Data Review Tools
Knowledge of Data Standardization methodologies and requirements
Experience processing clinical trial information
Clinical Knowledge
Understanding of clinical trial design
Basic medical terminology
Professional Skills
Strong organizational skills
Problem-solving ability
Negotiation skills
Time management
Initiative
Communication & Leadership
Strong communication skills
Confident and persuasive communicator
Ability to lead and facilitate meetings
Collaboration
Ability to work on multidisciplinary teams
Vendor management capability
Relationship management skills
Cultural Awareness
Awareness of local and global cultures
Ability to communicate effectively across diverse audiences
Language
English: Fluent (Read / Write / Speak)
]]>
Job details
How this role compares
Computed from every other active Data & Digital role in our database, not just this employer's listings.
We currently track 92 comparable Senior Data & Digital roles across 23 biopharma companies.
Salary context
16 of 92 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 92 comparable roles
+ 7 more countries
Seniority mix
92 of 92 peers have a known seniority level
Therapeutic area mix
2 of 92 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.