Developer, Clinical Data Applications – EDC Systems
Job in
Newton, Middlesex County, Massachusetts, 02165, USA
Listed on 2026-08-16
Listing for:
Jobtailor
Full Time
position Listed on 2026-08-16
Job specializations:
-
IT/Tech
Data Engineering, Data Analyst, Data Warehousing, Database Administrator
Job Description & How to Apply Below
- Drive activities related to the design, development, and maintenance of clinical study databases
- Collaborate with clinical study teams, Standards (CDASH/SDTM,CSL), and cross-functional stakeholders to define, implement, and continuously enhance data quality methods
- Oversee the implementation and maintenance of data quality control frameworks
- Govern and maintain a standardized library of reports and listings to support study teams
- Oversee the setup, automation, and monitoring of recurring data quality and operational reports
- Partner with Data Management, Statistics, and vendors to review and validate clinical data deliverables
- Lead the reporting solutions that provide insights into data quality, study progress, and key metrics
- Ensure appropriate data structures, storage, and integration approaches that enable pooled analyses
- Support the integration and governance of external data sources
- Contribute to innovation and future-state initiatives by supporting the development of scalable data platforms
- BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
- Medidata Rave Study Builder Certification is preferred
- 5+ years of relevant experience with clinical database design in EDC systems within a pharmaceutical or CRO environment
- Familiarity/practical experience with CDISC standards, particularly CDASH, SDTM including data mapping, validation, and activities supporting submission readiness
- Proficiency with EDC systems (e.g., Medidata Rave, Veeva Vault) and understanding of eCRF design and clinical data collection frameworks
- Strong understanding of clinical data processes, including data standards, data flows, and integration of eCRF and external data sources
- Proven ability to manage priorities, meet timelines, and operate effectively in a fast-paced and evolving environment
- Ability to independently perform data migration activities for post-production study changes is preferred
- Experience with C# is preferred and familiarity with SAS, Python, or R is a plus
Demonstrates expertise in clinical database design and data quality management, with a strong focus on EDC systems and CDISC standards. Proven ability to collaborate with cross-functional teams and oversee data integration and reporting solutions.
Highest-signal resume keywords- Clinical Database Design
- EDC Systems Proficiency
- CDISC Standards Familiarity
- Data Quality Control Frameworks
- Medidata Rave Study Builder Certification
- Clinical Data Processes
- Data Mapping
- Data Validation
- Data Migration
- ECRF Design
- C# Programming
- SAS Familiarity
- Python Familiarity
- R Familiarity
- Priority Management
- Timely Execution
- Adaptability
- Medidata Rave Study Builder Certification
- Pharmaceutical
- CRO Environment
- CDASH
- SDTM
- Data Quality Methods
- Medidata Rave
- Veeva Vault
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