CDM Programmer II – Veeva Vault EDC
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Location: Bangalore, India | Fully Remote
Job Type: Full-Time | Remote
Work Schedule: Second Shift (Afternoons)
Experience: Typically 4+ Years (Clinical Data Management / EDC Programming)
Qualification: Bachelor’s Degree or Equivalent in Relevant Discipline
Salary Range: Not Specified
Job Overview
Thermo Fisher Scientific is seeking a CDM Programmer II to support clinical trial data management activities using Electronic Data Capture (EDC) systems, particularly Veeva Vault EDC.
The CDM Programmer II will be responsible for database development, edit check programming, and clinical data validation activities to support clinical trials across multiple therapeutic areas. This role involves working closely with clinical data managers, programmers, and cross-functional teams to ensure high-quality clinical trial data collection and validation.
The position plays an essential role in clinical data management operations, helping ensure accurate, reliable, and regulatory-compliant data for clinical trial analysis and regulatory submissions.
Candidates in this role will also contribute to process improvements, technical problem resolution, and programming activities related to database configuration and data review tools.
Key Responsibilities
1. Clinical Database Development
Design, build, and configure clinical trial databases in Veeva Vault EDC.
Develop database structures and data collection forms for clinical studies.
Configure system parameters to ensure accurate data capture during trials.
Perform database testing and validation before deployment.
Support database updates and modifications during the clinical trial lifecycle.
2. Edit Check Programming & Data Validation
Design and implement edit checks to validate clinical trial data.
Develop automated data validation rules to detect inconsistencies and missing data.
Configure edit checks within EDC systems to maintain high data quality standards.
Test validation rules to ensure correct functionality within the system.
Support ongoing maintenance and updates of validation logic throughout the study.
3. Data Import & Data Integration
Define data structures for importing clinical trial data into the EDC system.
Import external datasets from laboratory systems or other clinical data sources.
Ensure proper mapping of external data to the clinical database.
Validate imported datasets to ensure accuracy and consistency.
Support integration of multiple data sources into the central clinical database.
4. Data Listings & Data Review Programming
Develop and test data listings used for clinical data review.
Create reports and listings to identify discrepancies in clinical datasets.
Support clinical data managers in reviewing and monitoring clinical trial data.
Perform programming tasks to support ongoing data review activities.
Ensure outputs align with project requirements and clinical data standards.
5. Study-Level Programming Leadership
Act as lead programmer for simple to moderately complex clinical studies under supervision.
Coordinate programming activities for assigned studies.
Research and resolve programming or database configuration issues.
Apply technical knowledge to manage programming tasks and deliver project requirements.
Support cross-functional teams with technical expertise.
6. Process Improvement & Operational Efficiency
Participate in initiatives to improve clinical data management processes.
Identify opportunities to enhance programming efficiency and automation.
Recommend improvements to database design or validation processes.
Support implementation of best practices within the data management team.
7. Compliance & Documentation
Ensure adherence to departmental SOPs and working practice documents.
Maintain documentation related to database configuration and programming tasks.
Follow regulatory guidelines governing clinical data management.
Support quality assurance activities related to database development and data validation.
Ensure compliance with standards defined by organizations such as the
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
Required Skills
Clinical Data Management Expertise
Understanding of clinical trial data collection and management processes.
Experience working with Electronic Data Capture (EDC) systems.
Knowledge of clinical database design and data validation processes.
Ability to identify data discrepancies and ensure data integrity.
Programming & Technical Skills
Working knowledge of programming and database tools including:
SAS programming
SQL
Veeva Vault EDC
Oracle Clinical / Medidata Rave
Experience developing edit checks and data validation rules.
Ability to troubleshoot programming issues and system configuration problems.
Problem Solving & Analytical Skills
Strong ability to identify technical problems and develop solutions.
Attention to detail when reviewing data validation logic and database configuration.
Capability to manage moderately complex programming tasks.
Ability to adapt to changing priorities in a project environment.
Project Management & Collaboration
Ability to manage multiple assignments and competing deadlines.
Experience working within cross-functional clinical trial teams.
Strong communication skills when coordinating with project stakeholders.
Capability to support project planning and timeline management.
Preferred Qualifications
Experience working with Veeva Vault EDC in clinical trials.
Prior experience in Clinical Data Management within CRO or pharmaceutical companies.
Experience supporting database development across multiple clinical studies.
Understanding of clinical trial regulations and industry standards.
Experience contributing to training materials or mentoring junior staff.
Key Competencies
Clinical database design and configuration
EDC programming and edit check development
Clinical trial data validation and quality assurance
Data integration and dataset management
Technical troubleshooting and process optimization
Cross-functional collaboration in clinical research teams
About the Company
Thermo Fisher Scientific is a global leader in scientific services and technologies, helping researchers and healthcare organizations accelerate scientific discovery and drug development.
Through its clinical research division, PPD Clinical Research Services provides comprehensive services across the clinical trial lifecycle, including clinical operations, data management, regulatory affairs, and medical writing.
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