Basic Purpose of the Job

Key contact partner in cultivating the "power of data" through:

1. Data collection/curation, data review and data delivery
2. Data standardization
3. 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
• Par