Key contact partner in cultivating the "power of data" by means of:
- Data collection/curation, data review, data delivery
- 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.
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
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
- 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
- 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
- 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
- Conduct and support training for Clinical Data Engineers
Success Measures
- Positive trainee feedback
- Increased knowledge sharing within the CDE Community of Practice
- 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
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
- Solves complex and defined problems
- Primarily operational with limited strategic impact
- Considers requirements and needs of other departments and functions
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.
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
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.
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)
- Knowledge of Data Collection Tools (EDC systems)
- Knowledge of Data Review Tools
- Knowledge of Data Standardization methodologies and requirements
- Experience processing clinical trial information
- Understanding of clinical trial design
- Basic medical terminology
- Strong organizational skills
- Problem-solving ability
- Negotiation skills
- Time management
- Initiative
- Strong communication skills
- Confident and persuasive communicator
- Ability to lead and facilitate meetings
- Ability to work on multidisciplinary teams
- Vendor management capability
- Relationship management skills
- Awareness of local and global cultures
- Ability to communicate effectively across diverse audiences
English: Fluent (Read / Write / Speak)
