Basic Purpose of the Job

Key contact partner in cultivating the "power of data" by means of:

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