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