Developer, Clinical Data Applications – EDC Systems

Jobtailor; Massachusetts; On-site; USD 110,000 - 170,000; Full time

Job summary

Jobtailor seeks a senior Clinical Data Specialist in Massachusetts to design and maintain clinical study databases. You will collaborate across study teams and standards groups to enhance data quality, implement QC frameworks, and drive scalable reporting solutions.

Qualified candidates have 5+ years in clinical databases within pharma/CRO, strong CDISC/CDASH/SDTM experience, and proficiency with Medidata Rave or Veeva Vault. ECRF design and data integration skills are valued.

Qualifications

• 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

Responsibilities

• 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.

Skills

Clinical Database Design

EDC Systems Proficiency

CDISC Standards Familiarity

Data Quality Control

Medidata Rave Certification

C# Programming

SAS Familiarity

Python Familiarity

R Familiarity

Data Mapping

Data Validation

Data Migration

ECRF Design

Education

BSc in Computer Science, Mathematics, Statistics or related area with relevant experience

Tools

Medidata Rave

Veeva Vault

Job description

• 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

Requirements

• 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

Core Competencies

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

ATS Optimization Keywords

Hard Skills

• Clinical Data Processes
• Data Mapping
• Data Validation
• Data Migration
• ECRF Design
• C# Programming
• SAS Familiarity
• Python Familiarity
• R Familiarity

Soft Skills

• Priority Management
• Timely Execution
• Adaptability

Certifications & Qualifications

• Medidata Rave Study Builder Certification

Industry Keywords

• Pharmaceutical
• CRO Environment
• CDASH
• SDTM
• Data Quality Methods

Tools & Technologies

• Medidata Rave
• Veeva Vault