Key contact partner in cultivating the "power of data" through:
- Data collection/curation, data review and data delivery
- 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.
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
- Quality project/TA deliverables
- Timeline adherence
- Feedback from ExpMED colleagues, Product Owners and capability managers
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
- Quality oversight deliverables
- Timeline adherence
- Stakeholder feedback
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
- Quality mindset
- Process improvement contributions
- Audit and inspection readiness
- Feedback from Product Owners, Quality Management and capability leaders
- 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
- Collaboration effectiveness
- Stakeholder satisfaction
- Influence across functions
- 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
- Innovation quality
- Regulatory acceptance
- Team and chapter feedback
- Deliver and support Clinical Data Engineering training
- Promote best practices
- Increase knowledge sharing across the CDE Community of Practice
- Training effectiveness
- Participant satisfaction
- Increased organizational capability
- Participate in or lead cross-functional BI process improvement initiatives
- Drive strategic CDE-related improvements
- Participate in external working groups and industry forums
- Leadership effectiveness
- Business impact of process improvements
- Feedback from Global Product Owners and Product Owners
Must understand and implement:
- 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
- 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
- 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
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.
Required:
- 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
- Strong curiosity and creativity in solving:
- Data collection challenges
- Data curation challenges
- Standardization issues
- Process and training challenges
- Many (≥ 6 years) of professional experience
- Pharmaceutical industry, CRO or academic research experience
- Leadership experience required
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
Bachelor's Degree or Master's Degree
Preferred fields:
- Life Sciences
- Computer Science
- Software Engineering
- Computer Engineering
- Related disciplines
- Deep expertise with:
- Electronic Data Capture (EDC) systems
- Data Collection Tools
- Data Review Tools
- Data Standardization methodologies
- Strong clinical trial design knowledge
- Understanding of medical terminology
- Extensive experience working with clinical trial information
- Leadership experience
- Vendor management expertise
- Training and coaching capability
- Meeting facilitation skills
- Strong communication skills
- Persuasive and influential communication style
- Ability to explain complex concepts clearly
- Organizational skills
- Problem-solving ability
- Negotiation skills
- Time management
- Initiative and ownership
- Ability to lead multidisciplinary teams
- Build strong vendor relationships
- Collaborate globally across cultures
- Ability to develop and deliver technical training programs
English: Fluent (Read / Write / Speak)
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
