Lead Clinical Database Programmer

Role Overview

• Develop, deploy, and maintain study databases to support clinical trial data collection, review, and analysis
• Configure study-specific builds within EDC systems and support integrations with external system (e.g., IRT, Central Labs, imaging, ePRO, eCOA, CTMS, eTMF)
• Design and create clinical databases optimized for data validation, review, and downstream analysis
• Assist in developing and maintaining clinical programming documentation
• Program, test, and validate electronic edit checks, data listings, and reports to ensure data integrity and usability
• Utilize programming languages (e.g., C#, SQL, SAS) to develop and test data outputs and reporting tools
• Perform and document all the database programming activities across the study lifecycle, including initial database build, mid-study updates, and database closeout
• Support post-production changes, enhancements, and issue resolution in a controlled and compliant manner
• Contribute to the development of appropriate study timelines for database build, validation, and deployment, ensuring alignment with overall study milestones
• Apply and promote CDISC standards (e.g., CDASH, SDTM) in database design and data structure
• Develop and maintain programming documentation, including specification, validation documentation, and change records
• Support regulatory inspections and internal audits by ensuring complete, accurate, and inspection-ready documentation
• Contribute to the development and continuous improvement of SOPs, standards, templates, and best practices for database programming
• Support the setup, validation, and maintenance of global libraries and standard templates
• Partner with Clinical Data Management, Biostatistics, Clinical Operations, and external vendors to translate protocol and study requirements into database specifications
• Provide technical expertise on EDC capabilities, system integrations, and database design decisions
• Build and maintain strong working relationships with internal teams and external partners supporting clinical trials
• Serve as technical lead and subject matter expert for clinical database programming
• Provide mentorship, guidance, and support to team members
• Drive consistency, efficiency, and continuous improvement across clinical database programming processes and tools

Requirements

• Master’s or bachelor’s degree in computer science/information technology or life sciences or related field.
• Minimum 5 years of experience in Clinical Database Programming.
• Knowledge of all the steps and documentations involved in a clinical database build process.
• Expertise in drug development processes (trial start-up/execution) and EDC database development.
• Proficiency in C-sharp, SQL, SAS, (Python or Java is a plus).
• Experience in reports/dashboard development.
• Proficiency in Clinical Data Management Systems (e.g., Medidata RAVE, Oracle/Inform).
• 3+ years of experience with Medidata RAVE CDMS is a plus.
• Proficiency in clinical database programming software and tools.
• Strong understanding of the clinical trial process, regulatory requirements (e.g., ICH-GCP), and good documentation process (GDP).
• Familiarity with clinical data standards (CDISC, CDASH) and coding standards (MedDRA / WHODrug).
• Experience with clinical technologies and regulatory submissions.
• Understanding of medical coding database structures (WHODrug, MedDRA).

Tech Stack

• Google Cloud Platform
• Java
• Oracle
• Python
• SQL

Benefits

• Must be willing to travel up to 10% of the time, as measured on a calendar quarter.