Senior Associate – Database Design
Department: Clinical Development / Clinical Data Management
Location: Hyderabad, India
Company: Amgen
Job ID: R-247296
Experience: 5–7 Years
Education: Bachelor's or Master's Degree in Life Sciences, Health Sciences, Computer Science, Pharmacy, Biotechnology, or related discipline
Role Summary
The Senior Associate – Database Design is responsible for translating clinical study protocol requirements into validated, scalable, and regulatory-compliant Electronic Data Capture (EDC) database solutions. The role supports end-to-end database development activities, including CRF design, edit check programming, workflow configuration, integration management, User Acceptance Testing (UAT), and database lifecycle management.
The incumbent collaborates with Clinical Data Management, Biostatistics, Clinical Operations, Medical Writing, Statistical Programming, and external vendors to deliver high-quality databases that support efficient clinical trial execution and regulatory submissions.
Key Responsibilities
1. Clinical Database Design & Development
Translate study protocol requirements into EDC database configurations.
Design and configure:
eCRFs (Electronic Case Report Forms)
Edit Checks
Derivations
Workflows
Custom Functions
Database Validation Rules
Support development within:
Veeva Vault CDMS
Medidata Rave
Similar EDC platforms
2. Metadata-Driven Database Development
Develop reusable metadata standards and templates.
Implement scalable database design methodologies.
Promote automation and standardization across studies.
Support enterprise-level metadata management initiatives.
3. Clinical Data Standards & Compliance
Ensure compliance with:
ICH-GCP Guidelines
FDA & EMA Requirements
21 CFR Part 11
Internal SOPs
Align database configurations with:
CDISC Standards
SDTM Requirements
Controlled Terminology Standards
4. User Acceptance Testing (UAT) & Validation
Develop and execute UAT plans.
Document testing results and validation evidence.
Identify, troubleshoot, and resolve database defects.
Support issue escalation and corrective actions.
Ensure inspection-ready documentation.
5. Data Quality & Risk Management
Support Risk-Based Quality Management (RBQM) initiatives.
Review discrepancy trends and data quality metrics.
Implement preventive and corrective database enhancements.
Contribute to risk mitigation planning.
6. Database Lifecycle Management
Support:
Database Build
Database Validation
User Acceptance Testing
Go-Live Activities
Mid-study Amendments
Database Lock Activities
Manage version control and change requests.
7. Cross-Functional Collaboration
Collaborate with:
Clinical Data Management
Clinical Operations
Biostatistics
Statistical Programming
Medical Writing
Regulatory Affairs
External Vendors
Study Teams
Ensure smooth delivery of database solutions aligned with study timelines.
8. External Data Integration
Support integration of:
Laboratory Data
Imaging Data
ePRO Data
Wearable Device Data
Other Non-CRF Data Sources
Coordinate with Data Acquisition and Technology teams.
9. Continuous Improvement
Support process optimization initiatives.
Develop reusable database standards.
Participate in lessons-learned exercises.
Contribute to organizational best practices.
Key Performance Indicators (KPIs)
Database delivery timelines
Database quality metrics
UAT defect rates
Database amendment cycle time
Audit and inspection readiness
Standards adoption and reuse
Cross-functional stakeholder satisfaction
Data quality outcomes
Required Qualifications
Education
Bachelor's Degree + 5 years relevant experience
OR
Master's Degree + 4 years relevant experience
Preferred disciplines:
Life Sciences
Pharmacy
Biotechnology
Health Sciences
Computer Science
Experience
5–7 years in:
Clinical Data Management
EDC Database Design
Clinical Research
Clinical Technology
Experience working in global clinical trials.
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