Clinical Database Programmer

Job Summary

The Clinical Database Programmer is responsible for the design, development, implementation, maintenance, and support of clinical databases and data management programming activities for clinical studies. This role ensures clinical trial data are collected, processed, validated, and delivered in accordance with applicable quality standards, regulatory requirements, and company procedures, resulting in high-quality, analysis-ready data.

The Clinical Database Programmer serves as a key technical resource within Clinical Data Management and works cross-functionally with Data Management, Statistics, Clinical Operations, Medical Affairs, and Information Technology teams to support the successful execution of clinical studies from study start-up through database lock and archival.

Essential Duties and Responsibilities

Clinical Data Management Programming

• Lead and execute end-to-end clinical database programming activities for assigned clinical studies.

• Design, build, configure, test, and maintain electronic data capture (EDC) databases according to study requirements and approved specifications.

• Develop and implement edit checks, derivations, form logic, field dynamics, and other database functionality to support data quality and study objectives.

• Create, validate, and maintain data transfer specifications and external data integrations.

• Perform loading, reconciliation, and processing of non-CRF data from external sources.

Study Execution and Data Quality

• Partner with study teams to define data collection requirements and ensure alignment with protocol objectives and regulatory expectations.

• Enforce data standards, data integrity principles, and quality expectations throughout the clinical data lifecycle.

• Review and provide input on data management plans, study documents, CRFs, edit check specifications, and related study documentation.

• Support study milestones by ensuring timely delivery of complete, accurate, and reliable clinical data.

• Contribute to database lock activities and support inspection and audit readiness as required.

Reporting and Technical Support

• Develop, test, and maintain reports, listings, dashboards, and data review tools using SQL, SAS, or other reporting technologies.

• Utilize data analytics and reporting solutions to facilitate data review, issue identification, and study oversight.

• Troubleshoot database and data management programming issues and collaborate with IT and system vendors to implement solutions.

• Serve as a technical subject matter expert for clinical database programming and EDC functionality.

Cross-Functional Collaboration

• Establish and maintain effective working relationships with cross-functional stakeholders involved in clinical study execution.

• Communicate study progress, risks, and technical considerations to project teams and management.

• Provide guidance and mentorship to other team members as appropriate.

• Participate in process improvement initiatives and contribute to the advancement of data management standards, tools, and best practices.

Continuous Improvement

• Identify opportunities to improve efficiency, quality, and consistency across clinical data management programming processes.

• Support implementation of new technologies, methodologies, and industry best practices.

• Contribute to departmental initiatives and organizational goals related to clinical systems and data management.

Education and Experience

Required Qualifications

• Bachelor's degree in Computer Science, Life Sciences, Information Systems, Mathematics, Statistics, or a related field; or an equivalent combination of education and relevant experience.

• Minimum of 3 years of clinical database programming or clinical data management experience within the pharmaceutical, biotechnology, medical device, or contract research organization (CRO) industry.

• Experience supporting clinical studies from database build through database lock and archival.

• Experience with Veeva CDMS, Veeva EDC, or equivalent electronic data capture platforms.

Knowledge, Skills, and Abilities

• Strong understanding of clinical trial processes, data management principles, and clinical data lifecycle activities.

• Knowledge of FDA, ISO, ICH-GCP, and applicable regulatory requirements governing clinical research and data management.

• Understanding of relational database design and data structures.

• Proficiency in SQL programming and data extraction techniques.

• Experience with EDC systems, preferably Veeva CDMS.

• Familiarity with MedDRA and WHO Drug coding dictionaries.

• Strong analytical, problem-solving, and troubleshooting skills.

• Ability to manage multiple priorities and meet project timelines in a fast-paced environment.

• Excellent written and verbal communication skills.

• Effective collaboration and stakeholder management skills within cross-functional teams.

• Proficiency with Microsoft Office applications and clinical research technologies.

Physical Requirements

• Ability to remain in a stationary position for extended periods of time.

• Frequent use of a computer, keyboard, and other office equipment.

• Ability to communicate effectively through written and verbal means.

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.

Work Environment

• Hybrid or remote work environment.

• Occasional travel up to 10% may be required based on business needs.